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

Model Number 1012270-12

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

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 85% stenosed, heavily calcified, and heavily tortuous lesion in the left anterior descending artery (lad).A 2.00x12mm mini trek rx balloon dilatation catheter (bdc) was advanced.When attempting to inflate the balloon the device was losing pressure, and contrast was leaking out from the side arm.The balloon failed to inflate, and was removed.The same inflation device was used with a non-abbott balloon, and the procedure was successfully completed.There were no adverse patient effects, and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak was able to be confirmed.The reported inflation problem was unable to be replicated in a testing environment due to the condition of the returned device.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.As there was no report of a leak during preparation for use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the inflation device was over torqued during connection to the hub resulting in the noted hub damages (crack, separation); thus resulting in the reported leak and inflation problem.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 10607469
• MDR Text Key: 209226133
• Report Number: 2024168-2020-08132
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138140
• UDI-Public: 08717648138140
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1012270-12
• Device Catalogue Number: 1012270-12
• Device Lot Number: 90820G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1