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

Model Number 1012270-30

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis. The reported inflation problem was able to be confirmed. Additionally returned goods analysis identified there was fluid was leaking from the tip at 16 atmospheres. There was a pinhole in the proximal taper of the balloon and a tear noted in the inner member. 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. 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 interaction with the guide wire and/or other devices resulted in the noted inner member tear, the noted scratched proximal balloon marker and the noted balloon material pinhole; thus resulting in the reported inflation problem/noted leaks (pinhole, tip). The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that a 2. 0x30mm mini trek rx balloon dilatation catheter failed to inflate. The procedure was successfully completed with an unspecified balloon catheter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Returned goods analysis identified there was fluid was leaking from the tip at 16 atmospheres. There was a pinhole in the proximal taper of the balloon and a tear noted in the inner member.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10708737
• MDR Text Key: 212287519
• Report Number: 2024168-2020-08761
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2021
• Device Model Number: 1012270-30
• Device Catalogue Number: 1012270-30
• Device Lot Number: 81212G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial