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

Model Number	1012451-20
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a circumflex artery.After implantation of an unspecified stent and re-crossing of the balance middleweight universal ll (bmw ll) guide wire (gw) to the circumflex artery, and although reaching the target lesion, resistance with the nc trek balloon over the gw was met and the balloon catheter fractured within the guide catheter (but remained in one piece).The nc trek and bmw ll gw were removed and replaced.A second bmw ll gw was attempted and also generated the same issue in resistance advancing with the balloon catheter.A new guide wire and balloon were 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.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty advancing the device over the guide wire and shaft break were not 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 identified no other similar incidents and/or complaints from this lot.The investigation determined the noted tear in the outer member on the returned device and reported difficulty advancing the device over the guide wire appear to be related to operational context.A conclusive cause for the reported break could not be determined.There was no damage noted to the nc trek bdc during the inspection prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Return analysis noted a pinhole sized tear located at the outer member distal to the mid lap seal.In this case, is likely that the bdc was inadvertently backloaded onto the guide wire not properly supported or at an angle such that the guide wire punctured through the outer member and subsequently resulted in the reported difficulty advancing the device.It is possible that the noted tear on the returned device is what the account perceived as the break in the shaft since they reported the balloon catheter fractured within the guide catheter (but remained in one piece); however, this cannot be confirmed since it was not possible to contact the physician for further follow up.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

• 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: 15521902
• Report Number: 2024168-2022-10205
• Device Sequence Number: 6078700
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Device Lot Number: 11104G1
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Sex: Female