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

Catalog Number UNK NC TRAVELER RX

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

Patient Problems Angina (1710); Hematoma (1884); Hemorrhage/Bleeding (1888); Ischemia (1942); Vascular Dissection (3160)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date estimated the udi is unknown due to the part/lot number was not provided.The customer reported the device is not returning.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 patient effects and malfunctions and devices reported in the article are captured under separate medwatch reports.Literature attachment.Article title: post-market clinical follow-up evaluation report coronary dilatation catheters.

Event Description

(b)(4): nc traveler rx.Title: post-market clinical follow-up evaluation report coronary dilatation catheters it was reported that the post market clinical follow-up evaluation was performed to collect and evaluate clinical data in real-world clinical settings to confirm safety and performance on the use of the following dilatation catheters: trek rx, mini trek rx, traveler rx, nc trek rx and nc traveler rx.The procedures were performed between january 2018 through june 2019.For the nc traveler rx dilatation catheter, the adverse patient effects include dissection, hemorrhage, hematoma, and unstable angina.Details are listed in the attached article, titled post-market clinical follow-up evaluation report coronary dilatation catheters.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot and part numbers were not provided.The reported patient effects of vascular dissection, angina, hemorrhage and hematoma are listed in the nc traveler rx coronary dilatation catheter instructions for use (ifu) as known patient effects of coronary stenting procedures.Based on the information reported through the research article, a definitive cause of the reported vascular dissection, ischemia, angina, hemorrhage, hematoma 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: UNK NC TRAVELER RX
• 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: 12619347
• MDR Text Key: 276655537
• Report Number: 2024168-2021-09156
• 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,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2021
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Male