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

Catalog Number UNK OTW MINI TREK

Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Advance (2524)

Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Perforation (2001); Vascular Dissection (3160)

Event Date 12/17/2020

Event Type  malfunction  

Event Description

The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report coronary dilatation catheters¿ evaluated the safety and performance of the trek rx, mini trek rx, traveler rx, nc trek rx, nc traveler rx, nc trek otw, trek otw, mini trek otw, and mini trek ii otw.It was reported through a pmcf report that the otw mini trek device may be related to unsuccessful delivery, inflation, or deflation, dissection, perforation, myocardial infarction, and arrhythmias.Although the above events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the abbott dilatation catheters met the safety and performance criteria.That they perform similarly to similar competitive devices.

Manufacturer Narrative

Date of event: the otw device data was collected using only method c2.The grouped data was collected from (b)(6) 2020 to (b)(6) 2021.The date of occurrence is unknown and estimated as (b)(6) 2020.The udi is unknown due to the part/lot number was not provided.Account unk united states as this report represents the survey data collected from the united states.This is a summary report.The device is not returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional devices, adverse events, and malfunctions indicated in the pmcf report are captured under separate medwatch report numbers.Article title: post market clinical follow-up evaluation report coronary dilatation catheters.

• 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: 12733940
• MDR Text Key: 283158941
• Report Number: 2024168-2021-09829
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• 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