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

Catalog Number 1013152-15

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The nc traveler 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 to treat a mildly calcified, mildly tortuous, 90% stenosed, de novo, mid left circumflex artery (mlcx) lesion.A 2.75x15mm nc traveler balloon dilatation catheter (bdc) was advanced to the lesion and inflated one time, to 9 atmospheres (atm) when the balloon ruptured.The device was simply removed.There were no adverse patient effects and no clinically significant delay in 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 identified no other similar incidents and/or complaints from this lot.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.

• 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
• MDR Report Key: 11074134
• MDR Text Key: 225806479
• Report Number: 2024168-2020-10942
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 1013152-15
• Device Lot Number: 00214G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1