NC TREK 1012454-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 08717648152092), received between Jan 26, 2017 and Apr 14, 2026 — classified as 8 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (34 reports).

2 FDA recall records 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 29, 2020Terminated

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

   Z-1133-2020 · Root cause: Process change control · FDA record ↗

2. Jan 29, 2020Terminated

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

   Z-1132-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO CALCIFICATION, NO TORTUOSITY AND 90% STENOSIS. THE 4.5X8 MM NC TREK BALLOON DILATATION CATHETER WAS INFLATED ONCE TO 12 ATMOSPHERES AND ALTHOUGH NEGATIVE PRESSURE WAS HELD FOR 16 SECONDS, THE DEVICE WAS NOT FULLY DEFLATED. THERE WAS RESISTANCE BETWEEN DEVICES DURING REMOVAL AND ALL THE DEVICES WERE REMOVED AS A UNIT WITH THE BALLOON STILL PARTIALLY INFLATED. THIS CAUSED THE STENT TO BE DRAGGED OUT. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED CHEST PAIN AND MYOCARDIAL TEAR INJURY. LOCAL DRUG TREATMENT WAS PROVIDED AND THE PATIENT WAS HOSPITALIZED ADDITIONAL TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Unspecified Tissue Injury

  MAUDE report 24874694 ↗
• InjuryDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 4.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION OF A STENT. AFTER DEFLATION OF THE DEVICE, DURING REMOVAL THE SHAFT SEPARATED, LEAVING THE DISTAL PORTION IN THE CORONARY ARTERY. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION HOWEVER WERE UNSUCCESSFUL THEREFORE THE DECISION WAS MADE TO TRANSFER THE PATIENT TO A DIFFERENT HOSPITAL FOR SURGERY WHERE THE SEPARATED PORTION WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704457 ↗
• InjuryMar 28, 2025Deflation Problem; Failure to Fold; Difficult to Remove; Deflation Problem; Failure to Fold; Difficult to Remove

  THE NMPA REPORT NUMBER IS (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). FOLLOWING THE DEPLOYMENT OF AN UNKNOWN STENT, A 4.5X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR POST-DILATATION; HOWEVER, THE BALLOON WAS NOTED TO FAIL TO DEFLATE AND FOLD PROPERLY. THE BDC WAS UNABLE TO BE REMOVED VIA THE INTRODUCER SHEATH, THEREFORE, THE BALLOON WAS PUNCTURED VIA AN ADDITIONAL ANGIOGRAPHY AND THE BDC WAS REMOVED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720611 ↗
• MalfunctionMar 13, 2025Deflation Problem; Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN UNKNOWN VESSEL. THE BALLOON OF THE 4.50X8MM NC TREK CORONARY BALLOON DILATATION CATHETER WAS INFLATED TWICE TO 12 ATMOSPHERES; HOWEVER, ONLY PARTIALLY DEFLATED AND COULD NOT BE REFOLDED BACK PROPERLY. WHEN ATTEMPTING TO REMOVE THE PARTIALLY DEFLATED BALLOON WITH FORCE, RESISTANCE WAS MET WITH THE UNSPECIFIED GUIDING CATHETER AND THE BALLOON SHAFT SEPARATED INTO SEPARATE PIECES. THE SEPARATED PORTION WAS WITHDRAWN ALONG WITH THE DELIVERY SYSTEM AND CATHETER. 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 21599809 ↗
• MalfunctionMar 4, 2025Deflation 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 4.50X8MM NC TREK CORONARY BALLOON DILATATION CATHETER PARTIALLY DEFLATED AND WHEN ATTEMPTING TO REMOVE THE PARTIALLY DEFLATED BALLOON RESISTANCE WAS FELT WITH THE GUIDING CATHETER AND THE SHAFT SEPARATED. THE SEPARATED PORTION WAS REMOVED ALONG WITH THE ENTIRE SYSTEM. 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 21517405 ↗
• MalfunctionApr 18, 2024Difficult 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 LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS 100% STENOSED. AFTER USING NC TREK RX 4.50 X 8MM BALLOON DILATATION CATHETER, DURING WITHDRAWAL, RESISTANCE WAS FELT WITH THE GUIDE CATHETER AND THE SHAFT SEPARATED IN TWO PIECES. THE BALLOON WAS STUCK IN THE FRONT END OF THE GUIDE CATHETER, AND THE BROKEN SECTION WAS WITHDRAWN FROM THE BODY TOGETHER WITH THE GUIDE CATHETER WITH FORCE, BUT NO INTERVENTION REQUIRED. THERE WERE NO REPORTED 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 19139956 ↗
• MalfunctionMar 29, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN ARTERY. THE 4.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATED TWICE TO NOMINAL PRESSURE. DURING REMOVAL THE BDC STUCK WITH THE GUIDING CATHETER. THE DEVICES WERE REMOVED AS A WHOLE UNIT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004066 ↗
• MalfunctionFeb 1, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS MODERATELY TORTUOUS. NEAR THE END OF THE PERCUTANEOUS CORONARY INTERVENTION PROCEDURE AND WITH THE FINAL POST DILATION COMPLETED, USING THE NC TREK RX 4.50 X 8MM BDC BALLOON, UPON REMOVING THE NC TREK BALLOON, IT GOT STUCK IN THE RADIAL SHEATH. IT WAS STATED THAT THERE WERE 4 INFLATIONS AT 12, 16, 16 & 18 ATMOSPHERES. IT WAS CONFIRMED THAT THE BALLOON WAS FULLY DEFLATED BEFORE REMOVAL AND THE STENT WAS WELL APPOSED TO THE VESSEL WALL. THE ENTIRE SYSTEM WITH NC TREK STILL INSIDE THE RADIAL SHEATH WAS REMOVED FROM THE ANATOMY. THERE WERE NO REPORTED 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 18624352 ↗
• MalfunctionOct 26, 2023Failure to Fold; Difficult to Remove; Difficult to Advance; Failure to Fold; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 4.5X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT WITH THE LESION. ONCE AT THE LESION THE BALLOON OF THE BDC WAS INFLATED ONCE TO 12 ATMOSPHERES (ATM) AND THEN INCREASED TO 14 ATM. THE BALLOON OF THE BDC WAS DEFLATED; HOWEVER, IT WAS NOTED THAT THE BALLOON DID NOT REFOLD PROPERLY AND WAS OBSERVED TO BE BUNCHED. RESISTANCE WAS FELT WITH THE ANATOMY DURING THE REMOVAL OF THE BDC AND AFTER SEVERAL ATTEMPTS THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A NON-ABBOTT DEVICE WAS USED 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 18013865 ↗
• MalfunctionSep 6, 2023Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED ABOUT 3-4 TIMES AT AN UNKNOWN PRESSURE, HOWEVER, THE BALLOON COMPLETELY FAILED TO DEFLATE AND WAS WITHDRAWN INFLATED. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. CONTRAST MIX USED WAS PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691426 ↗
• MalfunctionJul 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 4.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED AFTER 10 SECONDS DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY. PRIOR TO USE THE NC TREK BALLOON WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. A 5.0X8MM NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 17275340 ↗
• MalfunctionMay 22, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL RIGHT CORONARY ARTERY THAT IS 80% STENOSED. THE LESION WAS PRE-DILATATED WITH A 3.0X12MM NON-ABBOTT BALLOON AND STENTED WITH A 4.0X15MM NON-ABBOTT STENT. THE 4.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO PERFORM POST-DILATATION; HOWEVER, THE BALLOON COULD NOT BE INFLATED AFTER TRYING TO SEVERAL TIMES OR USING A NEW INDEFLATOR. IT WAS NOTED THE BDC WAS NOT SOAKED PRIOR TO USE AND WHEN ATTEMPTING TO INFLATE THE BDC WAS LOSING PRESSURE. AFTER THE DEVICE WAS REMOVED FROM THE ANATOMY IT WAS ATTEMPTED TO BE INFLATED AGAIN OUTSIDE THE PATIENT; HOWEVER, THE BDC KEPT LOSING PRESSURE AND COULD NOT INFLATE. IT IS BELIEVED THERE WAS A PINHOLE IN THE BALLOON. ANOTHER NC TREK 4.5X8MM BALLOON WAS USED TO POST-DILATE SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975585 ↗
• MalfunctionMay 12, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THE NC TREK BALLOON WAS SLOW TO DEFLATE AND REMOVED FULLY DEFLATED THROUGH THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919454 ↗
• MalfunctionApr 27, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 4.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED, HOWEVER, THE BALLOON GOT STUCK AT THE MOUTH OF THE GUIDING CATHETER DURING REMOVAL. THE GUIDING CATHETER, GUIDE WIRE AND BALLOON WERE ALL REMOVED AS A UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824716 ↗
• InjuryJan 26, 2023Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENT TO THE INITIALLY FILED EUMIR REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH HISTORY OF A DISSECTION. THE BALLOON WAS INFLATED 3 TIMES TO 20 ATMOSPHERES. NEGATIVE PRESSURE WAS HELD, THEN THE DEVICE RE-INFLATED, AND NEGATIVE PRESSURE HELD AGAIN AND THIS WAS REPEATED. THERE WAS NO HARM TO THE PATIENT DUE TO THE DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247910 ↗
• MalfunctionJan 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A CORONARY ARTERY. THE 4.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, DURING REMOVAL, THE BDC WOULD NOT INSERT INTO THE 6 FRENCH GUIDE LINER. THEREFORE, THE GUIDE LINER WAS PULLED BACK INTO THE GUIDE CATHETER AND THE BDC WAS PULLED INTO THE GUIDE CATHETER. ONCE THE BDC WAS IN THE GUIDE CATHETER THE BDC WAS ABLE TO PASS THROUGH THE GUIDE LINER AND BE REMOVED FROM THE PATIENT. 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 16210880 ↗
• MalfunctionJan 4, 2023Deflation 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 ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4.5X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED TO POST DILATE A STENTED LESION AND WAS INFLATED 7-8 TIMES UP TO 24 ATMOSPHERES. NEGATIVE WAS HELD TO DEFLATE THE BALLOON FOR 5 SECONDS. THE BALLOON WAS UNABLE TO FULLY DEFLATE POST DILATATION. THE BALLOON WAS ATTEMPTED TO BE PULLED BACK INTO THE GUIDE CATHETER AND IT WAS NOT ABLE TO PASS THROUGH AND GOT PARTIALLY STUCK. THE BALLOON AND THE GUIDE CATHETER WERE THEN REMOVED AS A UNIT. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE DEVICE WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE CONTRAST MIX WAS OMIPAQUE 50% AND SALINE 50%. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095205 ↗
• InjuryJan 3, 2023Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE 4.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE (IFU) DURING THE PROCEDURE TO TREAT A LESION IN A SAPHENOUS VEIN GRAFT, THE BDC WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. THE BALLOON WAS INFLATED TO 22 ATMOSPHERES (ATM) THE FIRST TIME WITHOUT ISSUE; HOWEVER, DURING THE SECOND INFLATION TO 22 ATM, THE BALLOON COMPLETELY FAILED TO DEFLATE. IT IS UNKNOWN HOW LONG NEGATIVE PRESSURE WAS HELD. THE INFLATED BALLOON WAS ATTEMPTED TO BE REMOVED WITH THE GUIDE CATHETER AND GUIDEWIRE (GW) AS A SINGLE UNIT; HOWEVER, DURING REMOVAL, THE TIP OF THE BALLOON CATHETER WHERE THE MARKER IS AND THE BALLOON SEPARATED, AND REMAINED COMPLETELY INFLATED. A GW WAS ADVANCED TO POKE A HOLE IN THE BALLOON; HOWEVER, THIS DID NOT WORK, SO A A CUTTING BALLOON WAS ADVANCED TO DEFLATE AND CRUSH THE SEPARATED PORTION INTO THE VESSEL WALL, FOLLOWED BY IMPLANTATION OF A NON-ABBOTT STENT TO PIN THE SEPARATED PORTION TO THE VESSEL WALL AND TO COMPLETE THE TREATMENT TO THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16091477 ↗
• MalfunctionDec 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, NO TORTUOSITY AND 90% STENOSIS. A 3.5 MM NON-ABBOTT BALLOON WAS USED FIRST AND THEN THE 4.5X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 12 ATMOSPHERES (ATM) ON THE SECOND INFLATION FOR FIVE SECONDS. WHEN INFLATED TO 18 ATM, THE BDC RUPTURED. A 4.5X12MM NC TREK BDC WAS USED AS A REPLACEMENT AND DURING THE FIRST INFLATION FOR 5 SECONDS THE BALLOON RUPTURED. THE NC TREK WAS REPLACED WITH A NON-ABBOTT BDC 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 16023826 ↗
• MalfunctionNov 29, 2022Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION; HOWEVER A KINK WAS OBSERVED. THEREFORE THE BDC WAS REMOVED FROM THE PATIENT AND DIFFICULTY WAS NOTED WITH THE GUIDE CATHETER. THE BDC AND THE GUIDE CATHETER HAD TO BE 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 15880472 ↗
• MalfunctionSep 14, 2022Failure to Fold; Failure to Deflate; Failure to Fold; Failure to Deflate

  IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE, THE 4.5 X 8MM NC TREK BALLOON MAY HAVE HAD A DEFLATION ISSUE AND MAY HAVE FAILED TO RE-WRAP. THERE WAS NO REPORT OF AN ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420384 ↗
• MalfunctionAug 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. A 4.5MM XIENCE SKYPOINT STENT WAS DEPLOYED AND A 4.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST DILATATION. THE BDC RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 15241634 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT, HOWEVER, THE BALLOON RUPTURED DURING THE PROCEDURE. THE DEVICE WAS SOAKED AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094193 ↗
• MalfunctionJul 19, 2022Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE 4.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC), THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH. THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE PATIENT ANATOMY AND THE CONTRAST MIX WAS 90 SALINE/10 CONTRAST. THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION. THE BDC WAS ADVANCED TO THE TARGET LESION AND INFLATED; HOWEVER, WHEN ATTEMPTING TO DEFLATE THE BALLOON AFTER THE FIRST INFLATION THE BALLOON DID NOT COMPLETELY DEFLATE; EVEN THOUGH, THE BALLOON WAS HELD AT NEGATIVE PRESSURE FOR AT LEAST 15 SECONDS. IN ORDER TO REMOVE THE PARTIALLY DEFLATED BALLOON, THE BDC WAS YANKED FROM THE PATIENT ANATOMY. 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 15056414 ↗
• InjuryJul 19, 2022Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN AN UNSPECIFIED ARTERY. THE 4.5X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AND FAILED TO DEFLATE WITH MULTIPLE ATTEMPTS. THE DEVICE WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. THE CONTRAST MIX WAS 10% CONTRAST AND 90% SALINE. A GUIDELINER WAS ADVANCED TO PUSH OVER AND REMOVED THE BALLOON THAT WAS STILL SOMEWHAT INFLATED. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052489 ↗