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

Catalog Number 1013151-15

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

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion located a the left circumflex artery that was heavily calcified and moderately tortuous.After soaking the nc traveler balloon system, it was advanced in the patient and air aspiration was performed.Once at the lesion, the balloon ruptured at 18 atmospheres during the first inflation.The device was removed without issue.There was no reported adverse patient effect and no clinically significant delay in the procedure.Cutting balloon angioplasty was then performed and another nc traveler balloon was used to continue the procedure, followed by deployment of a xience stent to complete procedure.No additional information was provided.

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.It was reported that the device was prepped inside the anatomy.It should be noted coronary dilatation catheters (cdc), nc traveler rx, global, (b)(4), instruction 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 compliant.The investigation determined the reported complaint 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 the device.The nc traveler is currently not commercially available in the us; however, it is similar to a device sold in the us.

• 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: 13896141
• MDR Text Key: 288292631
• Report Number: 2024168-2022-03148
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 1013151-15
• Device Lot Number: 00106G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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