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

Catalog Number 1013069-12

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 complaints from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture.It was reported that the device was prepped inside the anatomy.It should be noted that the coronary dilatation catheters (cdc), traveler rx, global, instructions for use (ifu) specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was performed to treat the right coronary artery that was 90% stenosed.The 3.0x12mm traveler balloon dilatation catheter was prepped (air aspiration) inside the anatomy prior to use.Pre-dilatation was attempted, however, the balloon ruptured at 12 atms during second inflation (the first inflation was at 10 atms).The device was removed without issue and replaced with a new same size traveler balloon to successfully continue the procedure.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: 11276304
• MDR Text Key: 231201957
• Report Number: 2024168-2021-00845
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 1013069-12
• Device Lot Number: 91125G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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