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

Catalog Number UNK TRAVELER RX

Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Advance (2524); Patient-Device Incompatibility (2682)

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

Event Date 07/01/2019

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 traveler rx may be related to unsuccessful delivery, inflation, or deflation, residual stenosis, unsuccessful achievement of timi 3 flow, 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

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. The udi is unknown due to the part/lot number was not provided. 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 traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us. The additional devices, adverse events, and malfunctions indicated in the attached pmcf report are captured under separate medwatch report numbers. Article title: post market clinical follow-up evaluation report coronary dilatation catheters.

• Brand Name: TRAVELER RX 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: 12733330
• MDR Text Key: 285756312
• Report Number: 2024168-2021-09810
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

0 Patients were 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

• Device Catalogue Number: UNK 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