MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-12

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

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 procedure was to treat a lesion located in the circumflex artery that was non calcified and non tortuous.During advancement of the trek rx 3.00 x 12mm bdc balloon over the guide wire, markers were not observed under x-ray.Therefore, the balloon catheter was removed, and no markers were physically present.It was decided to perform direct stenting to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.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 identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.However, factors that may cause the balloon marker to be missing and/or not visible under fluoroscopy include, but not limited to, manufacturing, location of anatomy and/or anatomical conditions, the type of contrast solution, contrast mixing ratio, patient anatomy, patient disease state and fluoroscopy equipment.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9, h3.The device is not available for evaluation.

• 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: 11852913
• MDR Text Key: 252222906
• Report Number: 2024168-2021-04225
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: 08717648138423
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 01221G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1