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

Model Number 1012268-12U

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.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 1.20x12mm mini trek pouch was creased and the device sterility was compromised.There was no damage to the chipboard box.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned packaged device and the reported creases and sterility issues were unable 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.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation determined the reported packaging creases and sterility issues appear to be related to operational circumstances of the procedure.It is likely that the noted indentations on the pouch caused the appearance of creases and they thought likely sterility issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 10273131
• MDR Text Key: 200683110
• Report Number: 2024168-2020-05805
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648176555
• UDI-Public: 08717648176555
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 1012268-12U
• Device Catalogue Number: 1012268-12U
• Device Lot Number: 91023G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1