MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-20

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 to treat a heavily calcified lesion located in the left main coronary artery.A guiding catheter was advanced and caused a dissection in the left anterior descending coronary artery.A non-abbott stent was implanted, and a perforation was noted.The trek rx balloon catheter was advanced, and post-dilatation was performed without issue, however, after balloon deflation, and during removal, resistance was noted, force was applied, and the distal shaft separated.All devices were removed as a single unit.The trek rx did not cause, contribute to any patient adverse effect, or a clinically significant delay in procedure.The patient was sent to surgery for repair of the perforation.Surgery was noted to be successful.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Additionally, it was noted that the balloon was wrinkled, the inner and outer members were stretched, and the proximal balloon marker was located distal to the proximal balloon seal.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 incidents from this lot.It should be noted that the trek rx and mini trek rx coronary dilatation catheter instructions for use.States: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.Although it was noted that resistance was noted during retraction, this was due to the device being trapped within the patients anatomy; therefore, the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified anatomy and/or other devices resulting in the reported difficult to remove.Manipulation of the device, using force, resulted in the noted device damages (balloon wrinkled, stretched inner/outer member, proximal balloon marker located distal to the proximal balloon seal) and ultimately resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 10577779
• MDR Text Key: 208773388
• Report Number: 2024168-2020-07976
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 90528G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR