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

Catalog Number	1012454-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the proximal right coronary artery.The patient was admitted for delayed st-segment elevation myocardial infarction (stemi) with ischemic cardiomyopathy and multi-vessel coronary artery disease (cad) was observed; however, not a candidate for coronary artery bypass graft (cabg).It was noted earlier that day the patient had an unspecified stent implanted.However, complications arouse and the patient was brought back.A perforation was observed and a unspecified covered stent was used.The 4.5x15mm nc trek balloon dilatation catheter (bdc) was advanced and inflated twice to 20 atmospheres for 12 seconds.During removal of the bdc, resistance with felt and it was observed that the tip of the bdc separated.It was attempted to snare the separated tip.However, it was unsuccessful.The patient died due to cardiogenic shock.Per the physician's opinion, the nc trek did not cause or contribute to patient's death.No clinically significant delay was reported.No additional information was provided.
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
Subsequently, after the initial report was filed it was noted the nc trek balloon met resistance with the guide wire during removal.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the guide wire; however, the reported separation, foreign body in patient and unexpected medical intervention appear to be related to operational context.Additionally, the reported patient death appears to be related to circumstances of the procedure as per the physician's opinion the nc trek did not cause or contribute to patient's death.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: 18023846
• Report Number: 2024168-2023-11938
• Device Sequence Number: 7683981
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: 08717648152115
• 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): 12/05/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1012454-15
• Was Device Available for Evaluation?: No
• 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: 10/27/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 65 KG