MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012447-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, 70% stenosed lesion in the circumflex (cx) artery.During preparation of a 2.50x15mm trek balloon dilatation catheter (bdc), difficulty was experienced when removing the stylet and protective sheath, however, the device was advanced to the lesion.The balloon was inflated up to two times, at 18 atmospheres (atm), however the balloon completely failed to deflate even after detaching the inflation device and pulling negative.The inflated balloon was pulled into a 7f sheath and remove from the anatomy.No replacement device was used.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported difficulty removing the mandrel/stylet and protective sheath could not be replicated in a testing environment because the components were not returned for analysis.The reported difficulty removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances.The reported tip tear was confirmed; however, the reported failure to deflate could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty removing the mandrel/stylet, protective sheath, or failure to deflate; however, the reported difficulty removing the device from the anatomy, tore tip and unexpected medical intervention appear to be related to circumstances of the procedure.Possible factors that can contribute to difficulty removing the mandrel/stylet may include, but not limited to, damage during protective sheath removal, removal technique or mishandling.Possible factors that may contribute to difficulty removing the protective sheath may include, but not limited to, manufacturing, normal variation within the manufacturing process or protective sheath removal technique.Additionally, possible factors that may contribute to failure to deflate the balloon include, but are not limited to, deflation technique, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.A conclusive cause for the reported difficulty removing the device from the mandrel/stylet, protective sheath or failure to deflate could not be determined.Furthermore, it was reported that difficulty was experience during attempts to remove the balloon, likely due to the balloon being removed inflated, as difficulty was encountered, and subsequently the distal tip of the balloon dilatation catheter (bdc) tore.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: negative was held for at least 20 seconds with recurrent pulls negative.The inflated balloon was pulled into a 7f sheath with resistance, at which point the distal tip of the device was torn, and the marker bands were noticed in the guide tip, however the device was remove from the anatomy without issue.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17219402
• Report Number: 2024168-2023-06902
• Device Sequence Number: 17700386
• Product Code: LOX
• UDI-Device Identifier: 08717648151767
• UDI-Public: 08717648151767
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 1012447-15
• Device Catalogue Number: 1012447-15
• Device Lot Number: 21109G3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown