MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012271-12

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

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 proximal shaft of a 2.25x12mm trek rx balloon dilatation catheter (bdc) was noted to be kinked.Additionally, the bdc was used and the balloon ruptured.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deformation due to compressive stress/kink was able to be confirmed.The reported material rupture was 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.Additionally, a review of the complaint history identified no other similar incidents from this lot.It should be noted that the trek rx and mini trek rx coronary dilatation catheter instructions for use (ifu) states: prior to use, examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.The reported material rupture was not confirmed and the deviation of the ifu does not appear to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during unpacking and/or preparation for use inadvertent mishandling resulted in the reported/noted deformation due to compressive stress/ outer member and bayonet kinks.Further mishandling resulted in the noted multiple hypotube bends.The reported material rupture was unable to be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 10120105
• MDR Text Key: 194045581
• Report Number: 2024168-2020-04760
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138218
• UDI-Public: 08717648138218
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1012271-12
• Device Catalogue Number: 1012271-12
• Device Lot Number: 80518G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR