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

Catalog Number 1013065-12

Device Problems Inflation Problem (1310); Material Split, Cut or Torn (4008)

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

Event Date 03/30/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous, de novo lesion in the right coronary artery (rca).A 2x12mm traveler balloon dilatation catheter (bdc) completely failed to inflate.The bdc was removed and another same size traveler balloon was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis noted a tear in the inner member of the device.

Manufacturer Narrative

The device was returned for analysis.The reported inflation issue could not be confirmed due to the condition of the returned device.Additionally, an inner member tear was noted during return device 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 similar incidents from this lot.There was no damage or leak noted to the balloon dilatation catheter (bdc) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.It is likely that the torn inner member prevented the inflation of the balloon.Factors that may contribute to torn inner members include, but are not limited to, material damage and interactions with other devices.There is no indication of a product quality issue with respect to manufacture, design or labeling.The traveler rx is currently not commercially available in the us; however, it is similar to a device sold in the us.

Manufacturer Narrative

H6: component code - additional code added.Narrative remains unchanged.

• 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: 12864999
• MDR Text Key: 281272838
• Report Number: 2024168-2021-10766
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 1013065-12
• Device Lot Number: 01125G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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