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

Model Number 1012270-12

Device Problems Inflation Problem (1310); Product Quality Problem (1506); Stretched (1601); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 99% stenosed, mildly tortuous lesion in the mid third circumflex coronary artery.Reportedly, a 2.00x12mm mini trek rx balloon dilatation catheter (bdc) presented a defect on its proximal edge portion of a non smooth surface, making it difficult to advance the guide wire and consequently failed to inflate the balloon.The procedure was successfully completed with an unspecified stent delivery system.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.The return device analysis identified that the inner member and outer member were stretched.

Manufacturer Narrative

The device was returned for analysis.The reported product quality problem/ irregular texture was unable to be confirmed; however there was noted inner and outer member damages (stretched, wrinkled, smashed).The reported difficult to advance and the reported inflation problem were able to be 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 from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling and/or manipulation of the device resulted in the reported product quality problem irregular texture/noted inner and outer member damages (stretched, wrinkled, smashed) thereby compromising the inflation lumen; thus resulting in the reported difficult to advance and the reported inflation problem.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9476893
• MDR Text Key: 177955079
• Report Number: 2024168-2019-14589
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138140
• UDI-Public: 08717648138140
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 1012270-12
• Device Catalogue Number: 1012270-12
• Device Lot Number: 81109G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1