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

Catalog Number	1012454-08
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
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 located in the right coronary artery that was moderately tortuous.Near the end of the percutaneous coronary intervention procedure and with the final post dilation completed, using the nc trek rx 4.50 x 8mm bdc balloon, upon removing the nc trek balloon, it got stuck in the radial sheath.It was stated that there were 4 inflations at 12, 16, 16 & 18 atmospheres.It was confirmed that the balloon was fully deflated before removal and the stent was well apposed to the vessel wall.The entire system with nc trek still inside the radial sheath was removed from the anatomy.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported difficulty could not be replicated in a testing environment due to the condition of the returned device.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 complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the introducer sheath.There was a separation of the hypotube located proximally from the proximal edge of femoral marker.Follow up was performed with the account and they confirmed that they were not aware of the separation.In this case, it is likely that the separation occurred during handling for packaging of the device to return to abbott vascular.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the previously filed report, returned device analysis revealed there was a separation of the hypotube located 27.4cm proximal from proximal edge of femoral marker.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: 18624352
• Report Number: 2024168-2024-01305
• Device Sequence Number: 7398216
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: (01)08717648152092(17)260228(10)30314G2
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 04/03/2024

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: 02/28/2026
• Device Catalogue Number: 1012454-08
• Device Lot Number: 30314G2
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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
• Patient Sex: Unknown