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

Catalog Number UNK OTW MINI TREK II

Device Problems Inflation Problem (1310); Off-Label Use (1494); Difficult to Remove (1528); Failure to Advance (2524); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

It was reported through the pmcf (post-market clinical follow-up) report, that the abbott otw mini trek ii coronary dilatation catheters (cdcs) that were used may be related to vessel dissection, arrhythmias including ventricular fibrillation, perforation, myocardial infarction.The report also found performance issues with the otw mini trek ii cdcs such as issues with delivery, inflation, deflation, and withdrawal.

Manufacturer Narrative

Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.The devices were not returned for evaluation.A review of the lot history records could not be conducted because the part and lot numbers were not provided.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.The additional patient effects listed in the report are captured under a separate medwatch report.

• Brand Name: MINI TREK II OTW 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: 15943977
• MDR Text Key: 305377579
• Report Number: 2024168-2022-12412
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK OTW MINI TREK II
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male