MAUDE Adverse Event Report: ABBOTT VASCULAR NC TRAVELER CORONARY DILATATION CATHETER

Catalog Number UNK NC TRAVELER RX

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

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

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: mean age based on c1 data.Sex: majority gender based on c1 data.Date of event: the report data included two different methods (c1 and c2), with two different data collection date ranges.The date of occurrence is unknown and estimated as (b)(6) 2019, the earliest date reported with the earliest collection method.D4: the udi is unknown due to the part/lot number was not provided.The additional devices, adverse events, and malfunctions indicated in the attached pmcf report are captured under separate medwatch report numbers.The traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.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.A definitive cause of the reported vascular dissection, myocardial infarction and arrhythmia 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.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 nc traveler rx may be related to unsuccessful delivery, inflation, or deflation issue, dissection, 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.

• Brand Name: NC TRAVELER 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: 12733597
• MDR Text Key: 279884180
• Report Number: 2024168-2021-09818
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103153
• 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: 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK NC TRAVELER RX
• 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
• Patient Outcome(s): Disability
• Patient Age: 62 YR