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

Model Number 1012274-30

Device Problem Deflation Problem (1149)

Patient Problem Angina (1710)

Event Date 02/17/2020

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 procedure was performed to treat a mildly calcified lesion in the proximal left anterior descending artery.A 3.0x30mm trek balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was inflated to 12-14 atmospheres; however, the balloon failed to fully deflate.After about 45 seconds, the balloon partially deflated and was removed.The patient had angina and it was managed subsequently.The procedure was successfully completed with a new unspecified trek bdc.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deflation problem was 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.A review of the complaint history identified no other incidents from this lot.The reported patient effect of angina is listed in the trek rx and mini trek rx coronary dilatation catheter instructions for use as a known patient effect of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.The investigation determined the reported deflation problem appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

Event Description

Additional information: the contrast mix was 50/50.The angina was treated with nitroglycerin.No additional information was provided.

• Brand Name: TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9831386
• MDR Text Key: 183482954
• Report Number: 2024168-2020-02411
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138461
• UDI-Public: 08717648138461
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1012274-30
• Device Catalogue Number: 1012274-30
• Device Lot Number: 90510G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1