MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-15

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 06/24/2021

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 during preparation and before use, the trek 3.0x15mm balloon dilatation catheter was prepped in the dispenser coil.Then, the balloon catheter was pulled out of the dispenser coil and it was observed that the balloon catheter was kinked and then separated in two pieces.There were no reported adverse patient effects and no clinically significant delay in the procedure.A new trek 3.0x15mm was used to continue the procedure.No additional information was provided.

Manufacturer Narrative

H6 medical device problem code 2017 incorrect prep.Visual inspection was performed on the returned device.The reported separation and kink were confirmed.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 did not indicate a lot specific quality issue.It was reported that the device was prepped inside the coil/hoop.It should be noted that the coronary dilatation catheters (cdc), trek rx, global, instruction for use (ifu) states: in step three to remove the protective sheath off the balloon before completing step four and five, which states prepare an inflation device with the recommended contrast medium according to the manufactures instructions and evacuate air from the balloon segment.In this case, it is unlikely that the reported ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported complaint.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: 12155766
• MDR Text Key: 261247486
• Report Number: 2024168-2021-05986
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138430
• UDI-Public: 08717648138430
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 1012274-15
• Device Catalogue Number: 1012274-15
• Device Lot Number: 01105G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1