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

Catalog Number 1013066-15

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaint from this lot. The investigation was unable to determine a conclusive cause for the reported inflation and deflation issues; however, the reported difficulty removing the device appears to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device. The traveler rx is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.

Event Description

It was reported that the procedure was performed to treat a 99% stenosed, moderately tortuous, and moderately calcified lesion in the mid left anterior descending artery. A 2. 25x15mm traveler rx balloon dilatation catheter (bdc) was prepared per the instructions for use and 50% contrast solution mix was used. The bdc was inflated twice at 8 atmospheres for 10 seconds during post-dilatation, but slow inflation was noted. During deflation, negative pressure was held for about 30 seconds; however, the balloon only partially deflated. The bdc was removed partially deflated and resistance with the anatomy was felt. The procedure was successfully completed therefore no replacement device was needed. 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: 12170686
• MDR Text Key: 261718149
• Report Number: 2024168-2021-06070
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 07/14/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 1013066-15
• Device Lot Number: 90131G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial