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

Catalog Number	1012449-20
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the mildly calcified, mildly tortuous left anterior descending coronary artery.A 3x20mm nc trek balloon dilatation catheter was prepped per the instructions for use and was attempted twice to inflate to 15 atm but completely failed to inflate, due to a hole that was noted on the balloon during inflation.An unspecified nc trek 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
Exemption number e2019001.The device was not returned for evaluation.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 circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 9233403
• Report Number: 2024168-2019-12914
• Device Sequence Number: 16775168
• Product Code: LOX
• UDI-Device Identifier: 08717648151880
• UDI-Public: 08717648151880
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• 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): 12/02/2019

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: 01/31/2021
• Device Catalogue Number: 1012449-20
• Device Lot Number: 80212G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 70