MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012272-15

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

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

Event Date 06/18/2021

Event Type  Injury  

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 the procedure was performed to treat a lesion in the left anterior descending coronary artery (lad).Prior to use, the mid-hypotube of the 2.5x15mm trek balloon dilatation catheter (bdc) was accidently bent.The user then straightened the bdc and inserted it into the anatomy.During the attempt to inflate, the bdc separated at the location of the bend.The separated segment was successfully snared.There was no adverse patient effect and no clinically significant delay in the procedure.A new trek bdc was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation and kink were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It should be noted that the coronary dilatation catheters (cdc), trek rx instruction for use (ifu), states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.Instead, prepare a new catheter.In this case, it is likely that the attempt to straighten and advance the kinked bdc into the anatomy contributed to the shaft separating.The investigation determined the reported kink appears to be related to operational context; however, the shaft separation appears to be related to user error.It was reported that even after a kink was noted, the device was advanced into the patient anatomy and the hypotube separated into two pieces.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 12145512
• MDR Text Key: 262181701
• Report Number: 2024168-2021-05894
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138294
• UDI-Public: 08717648138294
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1012272-15
• Device Catalogue Number: 1012272-15
• Device Lot Number: 10226G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 100