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

Model Number	1012451-12
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the mid-left anterior descending coronary artery that was non calcified and non tortuous.The lesion was pre dilated with an 2.5x12 nc trek and a 3.5 x 38 xience skypoint was deployed.Post dilatation was attempted with the nc trek; however, the guide wire met resistance coming out of nc trek at the tip of the catheter.The entire unit was pulled into the guide catheter, but the guide wire split the rapid exchange port on the catheter.All was successfully retrieved with no intervention.There was no reported adverse patient effect and no clinically significant delay in the procedure.The lesion was re-wired with a non-abbott guide wire and a new nc trek was advanced to post-dilate the stent.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported complaint was 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 reported split/tear of the rapid exchange port on the nc trek bdc appeared to be related to circumstances of the procedure.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.It was reported by the account that the guide wire met resistance coming out of nc trek at the tip of the catheter.In this case, it is likely that manipulation of the guide wire, when resistance was encountered, resulted in the reported split/tear of the rapid exchange port on the nc trek bdc.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.B5: description of event.
Event or Problem Description
Subsequent to the initial medwatch report, it was noted that the nc trek balloon dilatation catheter was a 3.5x12mm.The reported guide wire was a ht balance middleweight universal ii guide wire 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: 15547132
• Report Number: 2024168-2022-10349
• Device Sequence Number: 13942476
• Product Code: LOX
• UDI-Device Identifier: 08717648151972
• UDI-Public: 08717648151972
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: 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: 03/31/2025
• Device Model Number: 1012451-12
• Device Catalogue Number: 1012451-12
• Device Lot Number: 20411G2
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG