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

Catalog Number 1013158-12

Device Problems Break (1069); Deflation Problem (1149); Material Split, Cut or Torn (4008)

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

Event Date 01/25/2021

Event Type  malfunction  

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 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 a lesion in the mildly calcified, mildly tortuous left main coronary artery.A 4.5x12mm nc traveler balloon dilatation catheter (bdc) was advanced and inflated, but the balloon completely failed to deflate.The bdc was removed without issue.A 4.5x12 nc traveler balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional inspections were performed on the returned device.The reported break and tear were confirmed.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported break and tear appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Na.

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly calcified, mildly tortuous left main coronary artery.A 4.5x12mm nc traveler balloon dilatation catheter (bdc) was advanced and inflated, but the balloon completely failed to deflate.The bdc was removed without issue.A 4.5x12 nc traveler balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the inner member was noted to have separated during use while the outer member was intact, and a tear in the outer member was noted.There was no resistance during advancement or removal.No additional information was provided.

• 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: 11328024
• MDR Text Key: 233255211
• Report Number: 2024168-2021-01198
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 1013158-12
• Device Lot Number: 80717G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1