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

Model Number	1012452-15
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.A 3.75x15mm nc trek balloon was advanced over the guide wire when it became kinked and subsequently the mid-shaft broke (having not entered the anatomy yet).The device was simply removed altogether.Another nc trek balloon was used to successfully complete the procedure.There were no 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 separation and kink were 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 difficulties appear to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 11155901
• Report Number: 2024168-2021-00344
• Device Sequence Number: 3940261
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: 08717648152030
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 06/30/2023
• Device Model Number: 1012452-15
• Device Catalogue Number: 1012452-15
• Device Lot Number: 00729G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1