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

Catalog Number 1013065-12

Device Problems Inflation Problem (1310); Leak/Splash (1354); Product Quality Problem (1506); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The traveler device is not currently available commercially in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that after preparation of the 2. 0x12mm traveler balloon dilatation catheter, the balloon was not in proper shape. It was then pressurized outside of the patient, but the balloon did not hold pressure and failed to inflate. A leak was observed from the balloon. The procedure was then aborted. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

• 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: 11449084
• MDR Text Key: 240340939
• Report Number: 2024168-2021-01886
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1013065-12
• Device Lot Number: 00328G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial