MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-20

Device Problems Off-Label Use (1494); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

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 Description

It was reported that the trek rx dilatation catheter was prepped per instructions for use (ifu) without issue.There was no difficulty removing the proactive sheath.The device advanced to the left anterior tibial, moderately calcified lesion without unusual resistance.Upon initial inflation at 6 atmospheres, the balloon burst.Device aspirated was performed and the device was removed without further issues.Reportedly, the aspiration was not performed as a precaution and there was no air embolus.Another trek was successfully used in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

Manufacturer Narrative

Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported balloon rupture was not confirmed; however, the noted longitudinal tear in the inner member and balloon is likely what the account perceived as the reported balloon rupture.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 a potential product quality issue based on the noted longitudinal tear in the inner member and balloon which is likely what the account perceived as a reported balloon rupture.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Na.

Event Description

Subsequent to the previous medwatch report filed, the additional information was reported: the balloon burst at 6 atmospheres.There was no device aspiration performed due to this issue and no adverse patient effect.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10856573
• MDR Text Key: 217128524
• Report Number: 2024168-2020-09633
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 00110G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 89