NC TREK 1012455-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 08717648152139), received between Apr 17, 2017 and Jun 3, 2026 — classified as 13 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (38 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 16, 2026.

Recalls naming this device

1. Jan 29, 2020Terminated

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

   Z-1136-2020 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Entrapment of Device; Failure to Fold; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT CORONARY ARTERY LESION WITH 70% STENOSIS. THE 5X8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND USED FOR POST-DILATION OF A STENT. THE BDC WAS INFLATED TWICE AT 8 ATM AND 10 ATM. THE BALLOON WAS UNABLE TO BE FULLY DEFLATED DESPITE HOLDING 12 TO 14 SECONDS OF NEGATIVE PRESSURE. DURING REMOVAL, THERE WAS A POOR REWRAP OF THE BALLOON AND THE BDC WAS UNABLE TO BE WITHDRAWN THROUGH THE GUIDING CATHETER. A NEEDLE WAS USED TO PUNCTURE THE BALLOON TO FACILITATE REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS 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 25377234 ↗
• MalfunctionNov 20, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS. THE 5.0X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED 3 TIMES TO 12, 16 AND 18 ATMOSPHERES AND WAS HELD 5 SECOND FOR NEGATIVE PRESSURE. THE DEVICE WAS STUCK ON THE STENT POST DEPLOYMENT, AND THE SHAFT BROKE. THE DEVICE WAS WITHDRAWN WITH OTHER DEVICES AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS 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 23610256 ↗
• MalfunctionJul 24, 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 PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS. THE 5.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TWICE AT 12 ATMOSPHERES (ATMS) BUT COULD NOT BE FULLY DEFLATED. FORCE WAS APPLIED IN AN ATTEMPT TO RETURN THE BALLOON CATHETER TO THE GUIDING CATHETER AND THE BALLOON SHAFT SEPARATED INTO 3 PIECES. EVENTUALLY THE CATHETER WAS REMOVED TOGETHER WITH THE ENTIRE SYSTEM AND THE GUIDING CATHETER. NOTHING REMAINS IN THE PATIENT. 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 22591227 ↗
• InjuryJul 10, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION, HOWEVER, THE BDC FAILED TO ADVANCE DUE DUE TO THE ANATOMY. THE SHAFT OF THE BDC BECAME FRACTURED DURING ADVANCEMENT; THEREFORE, A BALLOON WAS USED TO ASSIST WITH REMOVAL OF THE BDC. THERE WAS A DELAY IN TREATMENT DUE TO THE BALLOON FRACTURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470613 ↗
• MalfunctionMay 19, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROXIMAL SEGMENT OF AN UNSPECIFIED STENT DID NOT ADHERE TO THE VESSEL WALL. THEREFORE, THE 5.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED HOWEVER, AFTER THE BALLOON WAS DEFLATED THE BALLOON BECAUSE STUCK WITH THE UNSPECIFIED GUIDE WIRE AND COULD NOT BE WITHDRAWN NORMALLY. THE DEVICES WERE WITHDRAWN TOGETHER. IT WAS NOTED THAT THE BDC WAS NOT SOAKED PRIOR TO USE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045499 ↗
• InjuryApr 18, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A NON-ABBOTT GUIDEWIRE WAS PASSED THROUGH THE LESION AND A 4.0X18MM STENT WAS DEPLOYED. A 5.0X8MM NC TREK BALLOON DILATATION CATHETER WAS INFLATED TO 12 ATMOSPHERES (ATM) TO POST DILATE THE PROXIMAL PORTION OF THE STENT. THE BALLOON WAS FULLY DEFLATED HOWEVER RESISTANCE WAS MET WITH THE ANATOMY AND GUIDING CATHETER DURING REMOVAL AND DURING THE PROCESS THE SHAFT SEPARATED. DESPITE REPEATED ATTEMPTS TO SNARE THE DEVICE, IT COULD NOT BE REMOVED. THE PATIENT WAS TRANSFERRED TO SURGERY FOR REMOVAL OF THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864708 ↗
• MalfunctionNov 1, 2024Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. THE 5.0X8MM NC TREK BALLOON DILATATION CATHETER WAS FULLY DEFLATED WHEN ATTEMPTING TO BE WITHDRAWN THROUGH THE GUIDING CATHETER; HOWEVER, WAS UNSUCCESSFUL AS RESISTANCE WAS FELT WITH THE GUIDING CATHETER. IT NOTED THE NC TREK WAS FULLY DEFLATED, BUT REFOLDED WINGED WITH AN IRREGULAR APPEARANCE. BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. 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 20587407 ↗
• MalfunctionMay 20, 2024Deflation Problem; Product Quality Problem; Difficult to Remove; Deflation Problem; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. FOR POST DILATATION THE 5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION AND THE BALLOON WAS INFLATED. HOWEVER, THE BALLOON WAS NOTED TO TAKE LONGER THAN USUAL TO DEFLATE. THE BDC WAS REMOVED FROM THE PATIENT AND DIFFICULTY WAS NOTED WITH THE GUIDE CATHETER DURING REMOVAL. THE PHYSICIAN FELT THE BDC WAS BULKY. THERE WAS NO ADVERSE 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 19354685 ↗
• InjuryMar 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 THE LEFT MAIN STEM (LMS) TO LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES WITH 70% STENOSIS IN THE LMS AND CALCIFICATION AND 80% STENOSIS IN THE LAD. THE TARGET LESION WAS TREATED WITH INTRAVASCULAR LITHOTRIPSY (IVL). THE 5.0X8 MM NC TREK BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. THE NC TREK BALLOON WAS INFLATED AND DEFLATED WITHOUT ISSUE; HOWEVER, DURING WITHDRAWAL, THE BALLOON CAUGHT ON THE PROXIMAL EDGE OF AN UNSPECIFIED STENT. SLIGHT FORCE WAS APPLIED AND THE NC TREK BALLOON SEPARATED. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED SEGMENT USING AN UNSPECIFIED 2.5X1.5 MM DEVICE IN THE GUIDING CATHETER; HOWEVER, THIS WAS UNSUCCESSFUL. A NON-ABBOTT SNARE DEVICE WAS THEN USED TO SUCCESSFULLY RETRIEVE THE SEPARATED BALLOON SEGMENT. THE PROCEDURE CONTINUED WITH A SECOND UNSPECIFIED NC DILATATION CATHETER. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923470 ↗
• MalfunctionJan 24, 2024Material Split, Cut or Torn; Failure to Deflate; Material Split, Cut or Torn; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A XIENCE STENT WAS IMPLANTED AND THEN THE 5X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. THE BALLOON WAS INFLATED TO 16 ATMOSPHERES BUT WOULD NOT DEFLATE. THE GUIDE CATHETER AND GUIDE WIRE HAD TO BE PULLED OUT OF THE ANATOMY AND THE BALLOON WAS STILL INFLATED. ON INSPECTION OUT OF THE ANATOMY, A HOLE WAS NOTED IN THE HYPOTUBE OF THE DEVICE. 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 18575942 ↗
• InjuryJan 8, 2024Deflation 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 TO TREAT AN ULCERATIVE LESION IN THE PROXIMAL SEGMENT OF THE RIGHT CORONARY ARTERY (RCA) AND OCCLUSION IN THE MIDDLE SEGMENT. A NON-ABBOTT STENT WAS IMPLANTED. THE 5.0X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION AND SHAPING, INFLATED 3 TIMES AT 14 ATMOSPHERES (ATMS) AND HELD NEGATIVE FOR 4-5 SECONDS. MULTIPLE ATTEMPTS WERE MADE BUT THE CATHETER COULD NOT BE RETRACTED SINCE IT FAILED TO DEFLATE AND WAS BEING WITHDRAWN INFLATED. THE SUSPENDED BALLOON COULD NOT BURST AT 30 ATMS IN THE RIGHT CORONARY SINUS. A NON-ABBOTT GUIDE WIRE WAS DRAGGED TO THE BRACHIAL ARTERY AND STILL COULD NOT PUNCTURE THE BALLOON. AT THE SAME TIME, THE BALLOON SHAFT WAS BROKEN AND SEPARATED INTO TWO PIECES. THE PATIENT COMPLAINED OF RIGHT ARM PAIN BUT NO TREATMENT WAS GIVEN. TEN MINUTES AFTER THE BALLOON BLOCKED THE VESSEL, THE BALLOON SHAFT STUMP WAS SQUEEZED AND DRAGGED IN VITRO BEFORE IT WAS REMOVED FROM THE SHEATH. BRACHIAL ARTERIOGRAPHY SHOWED NO EXTRAVASATION. AFTER REMOVING THE BALLOON AND COMPRESSION BANDAGING, THE PATIENT WAS RETURNED TO THE WARD FOR CLOSE OBSERVATION. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICAL

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 18466024 ↗
• MalfunctionJul 13, 2023Deflation Problem; Failure to Fold; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Failure to Fold; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  RETURNED DEVICE ANALYSIS IDENTIFIED AN INNER AND OUTER MEMBER SEPARATIONS SEPARATION; HOWEVER, THE ACCOUNT CONFIRMED THAT THE INITIALLY REPORTED INFORMATION DESCRIBED AS A RUPTURE HAD BEEN DESCRIBING THE INNER AND OUTER MEMBER SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317360 ↗
• MalfunctionApr 4, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 5.0X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE BUT WOULD NOT DEFLATE AFTER INFLATION. THIS PREVENTED THE BALLOON FROM BEING EASILY RETRIEVED THROUGH THE CATHETER DUE THE PROFILE OF THE BALLOON NOT FULLY DEFLATING. THE BALLOON WAS DEFLATED APPROXIMATELY 80%. THERE WERE NO ADVERSE PATIENT EFFECTS 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 16675433 ↗
• MalfunctionMar 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 5.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC)) WAS NOTED TO BE STUCK IN THE IN THE UNSPECIFIED CATHETER AFTER DEFLATION OF THE DEVICE. RESISTANCE WAS NOTED DURING REMOVAL OF THE BDC WITH THE UNSPECIFIED GUIDE CATHETER AND GUIDE WIRE. THE BDC WAS REMOVED AS A ONE UNIT ALONG WITH THE UNSPECIFIED CATHETER AND GUIDE WIRE. A NEW 5.0X12MM NC TREK BDC WAS USED; HOWEVER, SAME ISSUE OCCURRED AND DEVICES WERE REMOVED AS ONE UNIT. A NEW 4.0X18MM NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573667 ↗
• MalfunctionDec 1, 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 85% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 5.00X8MM 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 15898277 ↗
• MalfunctionNov 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RESTENOSIS IN THE LEFT MAIN CORONARY ARTERY (LM) WITH 75% STENOSIS, MODERATE CALCIFICATION AND NO TORTUOSITY. THE 5.0X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS INFLATED ONCE AT 10 ATMOSPHERES (ATMS) FOR 5 SECS, HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS SOAKED AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 15737353 ↗
• InjuryNov 4, 2022Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. AFTER POST-DILATATION OF AN IMPLANTED STENT WITH A 5X8MM NC TREK BALLOON AND DURING REMOVAL OF THE BALLOON, RESISTANCE WAS MET WITH THE ANATOMY. DUE TO THE RESISTANCE, THE DISTAL SHAFT BROKE IN TWO PIECES. THE PHYSICIAN ATTEMPTED TO PULL BACK THE SEPARATED DISTAL SHAFT WITH THE GUIDE WIRE AND PULL IT BACK IN THE GUIDE CATHETER TO GET IT BACK IN THE SHEATH. HOWEVER, THE SEPARATED DISTAL SHAFT DID NOT GO THROUGH THE SHEATH AND THEREFORE ANOTHER GUIDE WIRE HAD TO BE INSERTED, ADVANCED TO THE SIDE TO PULL THE SEPARATED DISTAL SHAFT INTO THE SHEATH AND IT WAS THEN ABLE TO BE ULTIMATELY REMOVED AS A SINGLE UNIT. IT WAS CONFIRMED THAT THE NC TREK BALLOON WAS FULLY DEFLATED BEFORE REMOVAL. THE PROCEDURE COMPLETED SUCCESSFULLY AT THIS POINT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727331 ↗
• MalfunctionSep 30, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE MET FROM THE ANATOMY. THE BALLOON WAS INFLATED ONE TIME TO 12 ATMOSPHERES (ATM), AND PRESSURE WAS HELD FOR 10 SECONDS WHEN THE BALLOON RUPTURED DUE TO THE CALCIFIED LESION. THE BDC WAS REMOVED WITHOUT ISSUE. 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 15521784 ↗
• MalfunctionSep 29, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 5.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE WITH THE LESION DURING ADVANCEMENT AND RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATMS). THE BDC WAS SOAKED IN SALINE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS NO RESISTANCE WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO RESISTANCE DURING REMOVAL. 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 15508874 ↗
• MalfunctionSep 28, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST DILATATION OF AN UNSPECIFIED STENT. THE BDC WAS INFLATED ONE TIME TO 16 ATMOSPHERES (ATM) INSIDE OF THE ANATOMY, HOWEVER THE BALLOON COULD NOT BE DEFLATED AND WAS REMOVED FROM THE ANATOMY FULLY INFLATED. OUTSIDE OF THE ANATOMY, THE CONTRAST WAS REMOVED FROM THE DEVICE AND REPLACED WITH SALINE HOWEVER THE BALLOON WOULD STILL NOT DEFLATE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499616 ↗
• MalfunctionApr 27, 2022Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT CORONARY ARTERY. THE NC TREK RX 5.00 X 8MM BDC COULD NOT BE COMPLETELY DEFLATED AND WAS WITHDRAWN AS A UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14227422 ↗
• MalfunctionApr 1, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 50% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. A 5.00 X 8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER THE BDC MET WITH RESISTANCE DURING ADVANCEMENT DUE TO ANATOMICAL CHALLENGES. DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 14 ATMOSPHERES; THEREFORE, BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO 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 13983223 ↗
• MalfunctionDec 23, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT MAIN STEM CORONARY ARTERY. TWO 5X8MM NC TREK BALLOONS MET RESISTANCE WITH A 6F NON-ABBOTT SHEATH DURING REMOVAL THUS ACCESS WIRE WAS LOST TWICE. RESISTANCE WAS ALSO REPORTED TO BE HAD WITH THE GUIDE CATHETER. THE BALLOONS WERE FULLY DEFLATED BEFORE ATTEMPTED REMOVAL. THE DEVICES WERE REMOVED ALTOGETHER WITH THE SHEATH. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079205 ↗
• MalfunctionDec 23, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT MAIN STEM CORONARY ARTERY. TWO 5X8MM NC TREK BALLOONS MET RESISTANCE WITH A 6F NON-ABBOTT SHEATH DURING REMOVAL THUS ACCESS WIRE WAS LOST TWICE. RESISTANCE WAS ALSO REPORTED TO BE HAD WITH THE GUIDE CATHETER. THE BALLOONS WERE FULLY DEFLATED BEFORE ATTEMPTED REMOVAL. THE DEVICES WERE REMOVED ALTOGETHER WITH THE SHEATH. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079169 ↗
• MalfunctionDec 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT MAIN TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A NON-ABBOTT STENT WAS IMPLANTED AT THE LESION. POST DILATATION WAS ATTEMPTED WITH A 5X8MM NC TREK BALLOON WHICH WAS INFLATED ONCE AT 14 ATMOSPHERES FOR 10 SECONDS WHEN IT RUPTURED. A NON-ABBOTT NON-COMPLIANT BALLOON 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 12955600 ↗