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

Catalog Number	1012447-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
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.The additional xience skypoint device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a bifurcation of a lesion in the anterior intraventricular artery (iva) and diagonal artery with moderate calcification and no tortuosity.The 2.5x12mm nc trek balloon dilatation catheter (bdc) was used successfully in the diagonal artery and removed without resistance.The xience skypoint stent was implanted successfully in the left anterior descending (lad) artery.The nc trek balloon was advanced again in the lad but without inflation.Another 2.75x12mm xience skypoint stent delivery system (sds) was attempted to be advanced but had resistance with the guiding catheter.The sds was removed, however, the stent dislodged in the guiding catheter.The stent was removed together with the guide catheter.The nc trek bdc was then removed without resistance but the distal shaft separated and a portion remained in the lad.Surgery had to be performed to retrieve the separated portion.There was no adverse patient sequelae.There was a clinically significant delay in the procedure and there was prolonged hospitalization.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported separation 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 separation, surgical intervention, delay in treatment therapy and hospitalization appear to be related to operational context.There was no damage noted to the balloon catheter prior to use, during preparation or during initial successful use in the diagonal artery, which suggests a product quality issue did not contribute to the reported difficulty.Return analysis noted that the material at the noted shaft separation was stretched and jagged which suggests that the separation may be related to tensile overload (material stress/fatigue).In this case, it is likely that, although no resistance was reported during removal, the bdc interacted with the other devices and/or patient anatomy, resulting in tensile overload (material stress/fatigue) during removal, such that the shaft separated.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Na.

• 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: 17999284
• Report Number: 2024168-2023-11800
• Device Sequence Number: 12260240
• Product Code: LOX
• UDI-Device Identifier: 08717648151750
• UDI-Public: 08717648151750
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/01/2023

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: 06/30/2026
• Device Catalogue Number: 1012447-12
• Device Lot Number: 30714G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATW CORDIS GUIDE WIRE; BMW GUIDE WIRE; VISTA BRITE CORDIS 6F GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male