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

Model Number	1012452-12
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified right coronary artery that was 90% stenosed.A 3.75x12mm nc trek balloon dilatation catheter was attempted to be advanced but failed to cross after several attempts due to unknown reasons, when the proximal shaft became separated.The device was simply withdrawn and no further intervention was performed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned device.The reported separation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: NC TREK RX & VOYAGER NC
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9598302
• Report Number: 2024168-2020-00752
• Device Sequence Number: 2499491
• Product Code: LOX
• UDI-Device Identifier: 08717648152023
• UDI-Public: 08717648152023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 03/31/2022
• Device Model Number: 1012452-12
• Device Catalogue Number: 1012452-12
• Device Lot Number: 90425G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1