NC TREK™ 1012455-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08717648152153), received between Mar 13, 2018 and Sep 30, 2026 — classified as 1 death, 13 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (22 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 29, 2020Class ITerminated

   Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

   Z-1138-2020 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Remove; Material Separation; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948651 ↗
• MalfunctionFeb 24, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUS FILED REPORT, IT WAS NOTED THAT THE OUTER MEMBER AND INNER MEMBER SEPARATED WHEN ATTEMPTING TO REMOVE THE NC TREK BALLOON DILATATION WITH THE UNSPECIFIED GUIDE WIRE. IT WAS NOTED THAT THE SEPARATED PORTION WAS SIMPLY WITHDRAWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21448348 ↗
• InjuryNov 21, 2024Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH 70% STENOSIS. AN UNSPECIFIED STENT WAS IMPLANTED AND THE 5.0X15 MM NC TREK BALLOON DILATATION WAS USED FOR POST-DILATATION. AFTER INFLATION THE BALLOON DID NOT DEFLATE PROPERLY AND COULD NOT ENTER THE 6FR THERAPEUTIC CATHETER. NUMEROUS ATTEMPTS WERE MADE TO REMOVE WITHOUT SUCCESS AND THEN THE SHAFT OF THE BALLOON BROKE. THE ENTIRE CATHETER SYSTEM WAS ATTEMPTED TO BE REMOVED WITH THE GUIDE WIRE AND THE INTRODUCER SHEATH BUT AGAIN THIS WAS UNSUCCESSFUL. THE 6FR INTRODUCER SHEATH WAS REMOVED FROM THE RIGHT RADIAL ARTERY DUE TO THE BALLOON BEING STUCK IN THE INTRODUCER SHEATH. ONLY BY REMOVING THE INTRODUCER SHEATH, LEAVING THE RADIAL ARTERY FREE, WAS IT POSSIBLE TO REMOVE THE BALLOON FROM THE RADIAL ARTERY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746706 ↗
• MalfunctionOct 23, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CORONARY ARTERY WITH STENOSIS. THE 5X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON DID NOT DEFLATE COMPLETELY AFTER HOLDING NEGATIVE FOR 10 SECONDS. DURING REMOVAL, THE BDC WAS NOT ABLE TO BE REMOVED INDEPENDENTLY; THEREFORE, THE BDC AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517021 ↗
• MalfunctionOct 14, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. AFTER NON-ABBOTT STENTS WERE DEPLOYED AT THE TARGET LESION, POST DILATATION WAS PERFORMED USING A 5X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC). IT WAS NOTED HOWEVER, AFTER DILATATION AND DEFLATION THE BDC WAS NOT ABLE TO BE REMOVED, AND THE BDC WAS REMOVED ALONG WITH THE GUIDING CATHETER AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440554 ↗
• DeathJul 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE MID LEFT MAIN CORONARY ARTERY. THE 5.00 X 15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED TO DILATE THE LESION; HOWEVER, AFTER REMOVAL IT WAS NOTED THAT THE BALLOON WAS SEPARATED IN THE ANATOMY. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED BALLOON HOWEVER WERE UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL FOR ADDITIONAL TREATMENT AND THE SEPARATED BALLOON WAS SURGICALLY REMOVED ON (B)(6) 2024. THE PATIENT DIED ON (B)(6) 2024. PER THE PHYSICIAN THE DEATH WAS RELATED TO THE SURGICAL REMOVAL OF THE SEPARATED DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798575 ↗
• MalfunctionOct 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION. THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, DURING REMOVAL THE BDC SHAFT BROKE IN THE GUIDE CATHETER. THERE WAS NO RESISTANCE DURING REMOVAL. AS THIS WAS THE END OF THE PROCEDURE, THE BDC WAS REMOVED WITHOUT ISSUE ALONG WITH THE GUIDE WIRE AND GUIDE CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959010 ↗
• InjuryJul 20, 2023Material Separation; Material Separation

  USER FACILITY MEDWATCH REPORT (4500440000-2023-8059) RECEIVED STATING: NC TREK CORONARY DILATATION CATHETER 5.00 LOT #: 20609G1, EXP DATE: 05/31/2025, BALLOON DETACHED FROM DEPLOYMENT CATHETER, THE SURGEON USED A SNARE TO REMOVE IT AND INSPECTED AND VERIFIED TO BE INTACT. SUBSEQUENT TO THE USER FACILITY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THERE WAS NO RESISTANCE DURING ADVANCEMENT AND REMOVAL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367405 ↗
• MalfunctionFeb 27, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. A 6FRENCH (FR) GUIDE CATHETER WAS ADVANCED AND A GUIDE LINER WAS INSERTED INSIDE THE GUIDE CATHETER FOR BETTER SUPPORT. THE 5.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND WAS USED, HOWEVER, THE SHAFT SEPARATED IN TWO PIECES INSIDE THE GUIDE CATHETER WHEN THE DEVICE WAS BEING RETRACTED. THERE WAS SLIGHT RESISTANCE WHEN REMOVING THE BDC FROM INSIDE THE GUIDE LINER. THE GUIDE CATHETER WAS REMOVED WITH THE SEPARATED SEGMENTS INSIDE. THE PHYSICIAN NOTED THERE MAY HAVE BEEN INTERACTION BETWEEN THE DEVICE AND THE GUIDE CATHETER. THERE WAS NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444162 ↗
• MalfunctionNov 23, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CHRONIC TOTAL OCCLUSION PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. AFTER STENT IMPLANTATION, THE 5.00X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND THE BALLOON WAS INFLATED TWICE FOR POST-DILATATION; HOWEVER, THE BALLOON WAS OBSERVED TO ONLY PARTIALLY DEFLATE. ALL DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. ANOTHER NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859139 ↗
• InjuryOct 12, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A OSTIAL RIGHT CORONARY ARTERY. THE 5.0X15MM NC TREK BALLOON DILATATION CATHETER WAS NOTED TO SEPARATE DURING REMOVAL OF THE DEVICE AS THE BALLOON GOT CAUGHT ON THE EDGE OF THE NON-ABBOTT GUIDE CATHETER. THE SEPARATED PIECE WAS SNARED FROM THE LEFT ILIAC ARTERY. ANOTHER NC TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586343 ↗
• MalfunctionAug 17, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. A NON-ABBOTT STENT WAS IMPLANTED AND THE 5.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED THROUGH A 6FR SHEATH. THE BDC WAS INFLATED THREE TIMES AT 12 ATMOSPHERES AND ONCE MORE AT 18 ATMOSPHERES. DURING REMOVAL OF THE BDC RESISTANCE WAS MET WITH GUIDE CATHETER AND THE SHAFT OF THE BDC SEPARATED. THE SEPARATED PORTION REMAINED IN THE GUIDE CATHETER AND WAS SIMPLY REMOVED. NO OTHER DEVICE WAS NEED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15244880 ↗
• MalfunctionJun 7, 2022Deflation Problem; Failure to Fold; Difficult to Remove; Deflation Problem; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. THE 5X15MM NC TREK BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE AND WAS INFLATED 4 TIMES WITHOUT PROBLEM. HOWEVER, AFTER POST-DILATATION, THE BALLOON WAS ONLY ABLE TO DEFLATE PARTIALLY. NEGATIVE WAS HELD FOR MORE THAN 1 MINUTE WHEN THE BALLOON WAS THEN ABLE TO BE DEFLATED COMPLETELY BUT DID NOT REFOLD PROPERLY WHICH MADE IT UNABLE TO BE REMOVED AS IT BECAME STUCK ON THE GUIDING CATHETER. TO REMOVE THE BALLOON, ALL DEVICES HAD TO BE REMOVED ALTOGETHER. DOPPLER IMAGING WAS PERFORMED TO VERIFY THE INTEGRITY OF THE RIGHT RADIAL ARTERY WHICH WAS CONFIRMED TO BE FINE. ANOTHER ACCESS SITE (RADIAL ARTERY) HAD TO BE ACCESSED TO PROCEED POST-DILATATION TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14625495 ↗
• InjuryMar 12, 2022Entrapment of Device; Failure to Deflate; Entrapment of Device; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION. AN UNSPECIFIED SKYPOINT STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THEN A 5.00 X 15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND WAS SUCCESSFULLY USED FOR POST DILATATION; HOWEVER, THE BALLOON FAILED TO DEFLATE CAUSING A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE BDC WAS UNABLE TO BE REMOVED FROM THE PATIENT; THEREFORE THE PHYSICIAN HAD TO PUNCTURE THE BALLOON WITH A RIGID WIRE AND THE BDC WAS REMOVED FROM PATIENT. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742248 ↗
• MalfunctionNov 22, 2021Deflation Problem; Failure to Fold; Difficult to Remove; Deflation Problem; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. A 5X15MM NC TREK BALLOON WAS ADVANCED TO THE LESION FOR POST-DILATATION. THE BALLOON WAS INFLATED ONCE AT 8 ATMOSPHERES BUT WHEN ATTEMPTED TO BE DEFLATED, NEGATIVE WAS PULLED FOR AT LEAST 30-40 SECONDS BUT THE BALLOON ONLY PARTIALLY DEFLATED. IT WAS ATTEMPTED TO TROUBLESHOOT BY INFLATING AND DEFLATING AGAIN, BUT FAILED TO DEFLATE COMPLETELY. THE BALLOON, GUIDE CATHETER AND GUIDE WIRE WERE REMOVED ALTOGETHER AS A SINGLE UNIT AS THE BALLOON WAS UNABLE TO BE WITHDRAWN SIMPLY VIA THE GUIDE CATHETER. THE PROCEDURE WAS DISCONTINUED THEREAFTER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED MDR, ADDITIONAL INFORMATION CONFIRMED THAT THE BALLOON DID NOT REFOLD PROPERLY WHEN ATTEMPTING TO BE DEFLATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856294 ↗
• MalfunctionOct 15, 2021Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY. THE 5.0X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE AND FULLY DEFLATED EACH TIME 5-10 SECONDS AT NEGATIVE PRESSURE; HOWEVER, THE BDC WAS NOTED TO BE WINGED AFTER BEING FULLY DEFLATED. THE BDC COULD NOT RETRACT INTO THE NON-ABBOTT GUIDE CATHETER. ADDITIONALLY, THE BDC AND THE NON-ABBOTT GUIDE CATHETER EXTENSION WERE RETRACTED INTO THE CATHETER AS ONE UNIT AND REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639954 ↗
• InjuryJul 9, 2021Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID AND PROXIMAL RIGHT CORONARY ARTERIES WITH SEVERE CALCIFICATION. THE 5.00X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD A CONTRAST MIX OF 50/50 AND WAS INFLATED TWICE TO 20 ATMOSPHERES (ATM). THE BALLOON WAS REPOSITIONED IN THE ARTERY BETWEEN INFLATIONS AND THERE WAS NO ISSUE DEFLATING THE BALLOON AFTER THE FIRST INFLATION. AFTER THE SECOND INFLATION, THE TREK BALLOON WOULD NOT DEFLATE AT ALL DESPITE MULTIPLE ATTEMPTS. NEGATIVE PRESSURE WAS APPLIED FOR 20-30 SECONDS. A SYRINGE WAS ALSO USED IN AN ATTEMPT TO DEFLATE THE BALLOON BEFORE IT WAS REMOVED. THE BALLOON WAS PULLED A FEW TIMES AND THE ENTIRE SYSTEM WAS REMOVED (BDC, GUIDE WIRE). AS THE BALLOON WAS STUCK WITH THE GUIDE WIRE, WIRE ACCESS WAS LOST. THE BALLOON SEPARATED AT THE PROXIMAL BALLOON MARKER AND REMAINED IN THE PATIENT. INSTEAD OF ATTEMPTING TO SNARE, ANOTHER GUIDE WIRE WAS PLACED SUB-INTIMALLY AND THE BALLOON WAS CRUSHED TO THE VESSEL WALL WITH 4.00X38 AND 4.00X15 MM XIENCE STENTS. POST-DILATATION WAS PERFORMED WITH ANOTHER 5.00X15 MM NC TREK BDC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12147619 ↗
• MalfunctionJan 15, 2021Deflation Problem; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE 5.0 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO TREAT IN-STENT RESTENOSIS IN THE RENAL ARTERY. THE BALLOON WAS INFLATED, TWICE, ONCE TO 20 ATMOSPHERES FOR 58 SECONDS AND THE SECOND TIME TO 8 ATMOSPHERES FOR 17 SECONDS. DURING DEFLATION, THE BALLOON DID NOT FULLY DEFLATE. NEGATIVE WAS HELD FOR A MINUTE OR MORE, MULTIPLE TIMES. THE BALLOON WAS REMOVED WITHOUT ISSUE, WITH THE BALLOON PARTIALLY INFLATED. THE PROCEDURE WAS COMPLETE AT THIS TIME, NO ADDITIONAL DEVICE WAS NEEDED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11182401 ↗
• InjurySep 15, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE RIGHT RENAL ARTERY. AN NC TREK 5X15MM BALLOON DILATION CATHETER (BDC) WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, WHEN ATTEMPTING TO DEFLATE THE BALLOON, IT WAS UNABLE TO DEFLATE AND PULL BACK INTO THE GUIDE. IT WAS NOTED THAT THE BALLOON HAD HALFWAY ENTERED THE GUIDE, BUT DUE TO THE DEFLATION ISSUE, BECAME STUCK. DUE TO THIS ISSUE, THE GUIDE WIRE AND SHEATH WERE UNABLE TO BE REMOVED AS WELL. THEREFORE, AN ADDITIONAL GUIDE WIRE WAS INSERTED, AND ALL THE DEVICE WERE ABLE TO BE REMOVED TOGETHER. AN ADDITIONAL BALLOON, GUIDE WIRE AND SHEATH WERE INSERTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535666 ↗
• InjurySep 3, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 4.0X28MM XIENCE SIERRA STENT WAS SUCCESSFULLY DEPLOYED. A 5.0X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED TO POST-DILATE THE STENT. THE BDC WAS INFLATED ONE TIME AT 12 ATMOSPHERES (ATMS) AND TWO MORE TIMES AT 10 ATMS. AN ATTEMPT TO DEFLATE THE BDC WAS MADE; HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED EVEN AFTER FIVE ATTEMPTS TO HOLD A NEGATIVE. AN INDEFLATOR WAS FILLED WITH SALINE AND A NEGATIVE WAS PULLED BUT THIS TOO FAILED. THE BALLOON PARTIALLY DEFLATED AND WAS REMOVED AS A UNIT WITH THE GUIDE WIRE, GUIDING CATHETER, AND INTRODUCER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE STENT DEPLOYMENT AND POST-DILATATION WITH THE 5.0X15MM NC TREK RX BDC. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED DUE TO ADDITIONAL RADIATION EXPOSURE TO THE PATIENT AND STAFF. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10489531 ↗
• MalfunctionAug 7, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE OSTIAL RIGHT CORONARY ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY. AN NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. AFTER INFLATION TO ABOUT 14 ATMOSPHERES, THE BALLOON ONLY PARTIALLY DEFLATED. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, BUT THE BALLOON ONLY PARTIALLY DEFLATED. THE DEVICE WAS RETRACTED BACK, AND AFTER A FEW TUGS, THE BALLOON WAS FREED FROM THE RCA, ENDING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382461 ↗
• MalfunctionJul 17, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. A XIENCE STENT WAS IMPLANTED AND THEN POST DILATED WITH A 5.0X15 NC TREK BALLOON DILATATION CATHETER; HOWEVER, THE BALLOON WOULD NOT DEFLATE. SEVERAL ATTEMPTS WERE MADE TO INFLATE THEN DEFLATE THE BALLOON, BUT THE BALLOON WOULD NOT DEFLATE. SUBSEQUENTLY, THE ENTIRE SYSTEM, INCLUDING THE GUIDING CATHETER, SHEATH AND THE 6FR SYSTEM WERE REMOVED AS A UNIT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292940 ↗
• MalfunctionApr 21, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE 5.00X15 MM NC TREK BALLOON FAILED TO DEFLATE DURING THE PROCEDURE. THE BALLOON WAS INFLATED 2-3 TIMES TO 14-16 ATMOSPHERES. NEGATIVE PRESSURE WAS HELD FOR ¿AGES,¿ BUT THE BALLOON WOULD NOT DEFLATE. A 50 ML SYRINGE WAS THEN USED ON NEGATIVE AND WAS ABLE TO PARTIALLY DEFLATE THE BALLOON, WHICH ALLOWED THE BALLOON TO BE PARTIALLY PULLED INTO THE GUIDING CATHETER AND REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9983763 ↗
• InjuryApr 10, 2020Deflation Problem; Difficult to Remove; Material Separation; Device Damaged by Another Device; Deflation Problem; Difficult to Remove; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ST ELEVATION MYOCARDIAL INFARCTION (STEMI) PATIENT. TWO STENTS WERE PLACED IN THE VEIN GRAFT. THE 5.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. MULTIPLE INFLATIONS WERE PERFORMED. THE BALLOON DID NOT DEFLATE, THE BDC WOULD NOT PULL BACK INTO THE GUIDE CATHETER. DIFFERENT ATTEMPTS WERE MADE TO REMOVE THE BDC; HOWEVER, IN THE END THE BALLOON SNAPPED OFF INSIDE THE GUIDE CATHETER. THE DEVICES WERE REMOVED AS A SINGLE UNIT. AFTER ALL THIS, THE IMPLANTED STENTS WERE OBSERVED TO BE DAMAGED. TWO ADDITIONAL STENTS WERE IMPLANTED, COVERING THE DAMAGED STENTS. THE PATIENT WAS STABLE AND THE PROCEDURE WAS FINISHED SAFELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950536 ↗
• MalfunctionFeb 11, 2020Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. THE 5.0X15MM NC TREK BALLOON FAILED TO DEFLATE. THE BALLOON CATHETER WAS REMOVED WHILE THE BALLOON WAS STILL INFLATED, AND RESISTANCE WAS MET WITH THE GUIDING CATHETER. THE NC TREK, GUIDING CATHETER, AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. DURING THE PROCESS, FORCE WAS APPLIED AND THE SHAFT SEPARATED. ALTHOUGH A CLINICALLY SIGNIFICANT DELAY WAS REPORTED, THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9696319 ↗