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

Catalog Number UNK OTW MINI TREK II

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

The otw device data was collected using only method c2.The grouped data was collected from 12/17/2020 to 01/18/2021.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 attached pmcf report are captured under separate medwatch report numbers.Literature attachment.Article title: post market clinical follow-up evaluation report coronary dilatation catheters.

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 ii 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

B3: 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.D4: the udi# is unknown because the part and lot numbers were not provided.D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.E: account unk united states as this report represents the survey data collected from the united states.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.The patient effects listed are consistent with the product risk profile and are therefore expected.A definitive cause of the reported dissection, perforation, arrhythmia, myocardial infarction and the relationship to the product, if any cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 12733897
• MDR Text Key: 280081313
• Report Number: 2024168-2021-09833
• 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: 11/17/2021

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK OTW MINI TREK II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2021
• 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
• Patient Outcome(s): Disability