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

Catalog Number 1013067-15

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 90% stenosed lesion in the distal right coronary artery (drca).A 2.5x15mm traveler balloon dilatation catheter (bdc) was advanced to the lesion with resistance from the anatomy and inflated one time to 6 atmospheres (atm) when a leak of contrast was noted coming from the device.The bdc was removed with resistance from the anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.A new traveler bdc was used to successfully complete the procedure.No additional information was provided.

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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulty advancing and removing the device from the anatomy appear to be related to circumstances of the procedure; however, a conclusive cause for the reported leak could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The traveler is currently not commercially available in the us; however, it is similar to a device sold in the us.

• 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: 15127101
• MDR Text Key: 304694136
• Report Number: 2024168-2022-08328
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013067-15
• Device Lot Number: 10721G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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