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

Catalog Number	1012452-20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
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 lesion in the proximal right coronary artery (prca) with stenosis.The 3.75x20mm nc trek balloon dilatation catheter (bdc) was used for post dilatation and inflated two times, however, during the second inflation, the balloon did not maintain pressure.First assumption was that the balloon had burst but there was no visible leakage from the balloon.Upon removal without resistance, only the proximal shaft was retrieved.With the help of an additional wire, the separated portion of the shaft was able to be pulled back into the catheter and removed the entire system.Another nc trek balloon was used to complete the procedure.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.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 complaint and unexpected medical intervention appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the proximal right coronary artery (prca) with stenosis.The 3.75x20mm nc trek balloon dilatation catheter (bdc) was used for post dilatation and inflated two times, however, during the second inflation, the balloon did not maintain pressure.First assumption was that the balloon had burst but there was no visible leakage from the balloon.Upon removal without resistance, only the proximal shaft was retrieved.With the help of an additional wire, the separated portion of the shaft was able to be pulled back into the catheter and removed the entire system.Another nc trek balloon was used to complete the procedure.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: there was no resistance during advancement.No additional information was provided.

• Brand Name: NC TREK RX 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: 18306471
• Report Number: 2024168-2023-13804
• Device Sequence Number: 17708914
• Product Code: LOX
• UDI-Device Identifier: 08717648152047
• UDI-Public: 08717648152047
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/15/2024

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: 12/31/2025
• Device Catalogue Number: 1012452-20
• Device Lot Number: 30123G1
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: CORDIS GUIDING JR4 6F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown