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

Model Number	1012449-08
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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.The additional device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the moderately calcified, moderately tortuous left anterior descending coronary artery.After an unspecified stent was implanted, a 3x8mm nc trek balloon dilatation catheter (bdc) failed to cross the lesion due to the anatomy, and the proximal shaft separated into two pieces.The bdc was simply withdrawn without resistance.A 2.75x8mm nc trek bdc also failed to cross the lesion due to the anatomy, and the proximal shaft separated into two pieces.The bdc was simply withdrawn without resistance.Then a 2.5x8mm nc trek bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically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, dimensional and functional inspections were performed on the returned device.The reported separation and tear were 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 identified no other similar incidents and/or complaints from this lot.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.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the moderately calcified, moderately tortuous left anterior descending coronary artery.After an unspecified stent was implanted, a 3x8mm nc trek balloon dilatation catheter (bdc) failed to cross the lesion due to the anatomy, and the proximal shaft separated into two pieces.The bdc was simply withdrawn without resistance.A 2.75x8mm nc trek bdc also failed to cross the lesion due to the anatomy, and the proximal shaft separated into two pieces.The bdc was simply withdrawn without resistance.Then a 2.5x8mm nc trek bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: during prep, the 2.75x8mm nc trek balloon was slightly inflated to check for any leak.A tear in the guide wire exit notch of the 3x8mm nc trek balloon was noted.No additional information was provided.

• 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: 11463132
• Report Number: 2024168-2021-01930
• Device Sequence Number: 19856383
• Product Code: LOX
• UDI-Device Identifier: 08717648151859
• UDI-Public: 08717648151859
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 05/31/2021
• Device Model Number: 1012449-08
• Device Catalogue Number: 1012449-08
• Device Lot Number: 80618G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1