MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER

Model Number 1012270-15

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 of the 2.00x15mm mini trek balloon dilatation catheter, a leak was observed at the distal marker/shoulder of balloon.The device was not soaked prior to pressurizing.It was wiped down with a wet gauze.There was no patient involvement.Therefore, there were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 (ifu) states: note: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating.It is undetermined if the deviation of the ifu caused/contributed to the reported leak.It is possible that wiping down the device with a wet gauze and not soaking the balloon during preparation of the device resulted in compromising the balloon material, thus resulting in the reported leak observed at the distal marker/shoulder of balloon during preparation for use; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3 - device available for eval updated from yes to no.

• Brand Name: MINI 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: 10560444
• MDR Text Key: 207738436
• Report Number: 2024168-2020-07844
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138157
• UDI-Public: 08717648138157
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1012270-15
• Device Catalogue Number: 1012270-15
• Device Lot Number: 91217G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1