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

Model Number	1012450-12
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during a heavily tortuous, heavily calcified left anterior descending coronary artery intervention, as a 3.25x12mm rx nc trek balloon dilatation catheter (bdc) was being advanced, resistance was noted with the anatomy and the guide catheter.The shaft bent while advancing through the guiding catheter and the balloon never reached the lesion.The bdc was withdrawn with resistance noted with the guiding catheter.There was no reported adverse patient effect or clinically significant delay in the procedure.Another unspecified device successfully completed the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported deformation due to compressive stress/kink was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.The reported difficult to remove was not confirmed.The following was noted during device evaluation: kinked support skive/wire/bayonet/support mandrel/outer member, wrinkled outer member, multiple bends.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily tortuous and heavily calcified anatomy resulting in the reported failure to advance.Manipulation of the device resulted in the reported/noted device damages (kinked support skive/wire/bayonet/support mandrel/outer member, wrinkled outer member, multiple bends); thus resulting in the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 10621831
• Report Number: 2024168-2020-08231
• Device Sequence Number: 11696213
• Product Code: LOX
• UDI-Device Identifier: 08717648151927
• UDI-Public: 08717648151927
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 12/31/2022
• Device Model Number: 1012450-12
• Device Catalogue Number: 1012450-12
• Device Lot Number: 00114G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1