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

Catalog Number 1013151-15

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/09/2022

Event Type  malfunction  

Event Description

It was reported that during inventory management, the dealer found that the chinese label was inconsistent with the english label.After verification, 15 nc traveler balloon dilatation catheters (bdc) were found in the distributor's inventory with english labeling: part #: 1013151-15, lot #: 20131g1 which is for a 2.5x15mm nc traveler and with chinese labeling: part #: 1013153-15, lot #: 20203g1 which is for a 3.0x15mm nc traveler.There was no device use or patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.

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 additional nc traveler devices are being filed under separate medwatch report numbers.The nc traveler balloon dilatation catheter is currently not commercially available in the us; however, it is similar to a device sold in the us.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported device markings / labelling problem was confirmed.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed similar complaints from this lot which are associated with the exception issue.The investigation determined a potential product quality issue based on the reported and confirmed mismatching information between the addendum label and the product label.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Na.

• Brand Name: NC TRAVELER 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: 16057438
• MDR Text Key: 306826473
• Report Number: 2024168-2022-13159
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013151-15
• Device Lot Number: 20131G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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