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

Catalog Number 1012268-12

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.The additional mini trek referenced is filed under a separate medwatch report number.

Event Description

It was reported that the distributor received a mini trek (part number 1012268-12, lot number 80615g1), which was not registered in (b)(6).There was no patient involvement.No additional information was provided.

Manufacturer Narrative

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 of the reported lot identified one similar complaint from this lot for this potential product quality issue therefore it is associated to the exception.The complaint device was not returned to abbott for analysis.Further assessment of the reported issued was conducted.An affiliate in china retrieved 7 sterile devices (5 nc trek and 2 mini trek) through a social media application, wechat, in china as it is possible that the mini trek under investigation was retrieved through the same or similar channel.The purchased units were evaluated for authenticity of design and manufacture by comparing them to verify packaging and labeling materials approved for use by abbott.The chipboard box label number, instructions for use (ifu) number and the pouch label number were recorded for each of the inspected units on the data collection sheet.The recorded data were checked against the corresponding approved documents released in abbott viewpoint and confirmed to be authentic.The verification confirmed that the labels present on the product are consistent with the labels used in the manufacturing process at abbott.Additionally, a thorough investigation performed by abbott west distribution center concluded that the distribution of unregistered mini trek rx could not have been attributed to abbott distribution processes.This conclusion is appropriate because the addendum label for china cannot be printed with mini trek rx part# 1012268-12 and china addendum label build method, is not programmed to include mini trek rx part# 1012268-1.Based on a thorough investigation, it was determined that the distribution of unregistered mini trek rx could not have been attributed to abbott distribution processes.This conclusion is appropriate because the addendum label for china cannot be printed with mini trek rx part numbers and china addendum label build method is not programmed to include mini trek rx part numbers.Therefore, there is no product quality issue with respect to the design, manufacture or labeling of the device.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 10038931
• MDR Text Key: 191843895
• Report Number: 2024168-2020-04187
• Device Sequence Number: 1
• Product Code: LOX
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 1012268-12
• Device Lot Number: 80615G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1