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

Catalog Number	1012445-15
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.Visual inspection was performed on the returned device.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Device analysis noted that the hypotube was separated distal to the nose of the hub and the balloon had a radial rupture distal to the proximal balloon marker.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 incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported failure to advance.A conclusive cause for the noted shaft separation and balloon ruptures could not be determined since limited information was reported.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the nc trek did not cross the calcified and moderately tortuous lesion for this patient, however, it was not due to patient anatomy.The patient was treated with competitor device to complete the procedure.There were no other device issues noted.The patient experienced no untoward effects as a result of the failure to cross and there was no reported clinically significant delay in the procedure.No additional information was provided.Device analysis revealed a balloon rupture and proximal shaft separation, however, after follow up with the customer, it is not known when the rupture of the balloon and the proximal shaft separation occurred.This did not occur during use in the patient, nor was any injury to the patient reported.The device was prepped without issue and according to the instructions for use.The correct device was returned.No additional information was provided.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9194454
• Report Number: 2024168-2019-12635
• Device Sequence Number: 3671637
• Product Code: LOX
• UDI-Device Identifier: 08717648151651
• UDI-Public: 08717648151651
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 10/31/2021
• Device Catalogue Number: 1012445-15
• Device Lot Number: 81103G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1