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

Model Number 1012455-20

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Material Separation (1562)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion with no calcification and no tortuosity in the saphenous vein graft (svg) to right coronary artery (rca).The nc trek balloon catheter was advanced to the target lesion and the balloon was inflated twice to 8 atmospheres (atm) and 12 atms without issue.The balloon deflated without issue.However, during removal of the balloon catheter, the balloon was winged and could not be withdrawn into the guiding catheter.And during the attempt to withdraw the balloon catheter, the distal shaft separated and remained on the guide wire.Therefore, all the devices had to be removed as one unit.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported winged balloon and distal and proximal separations were confirmed; however, the reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 was unable to determine a conclusive cause for the reported winged balloon; however, the reported difficulty removing the device and distal and proximal separations appear 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 TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11801008
• MDR Text Key: 250384064
• Report Number: 2024168-2021-03947
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

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: 07/31/2023
• Device Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Device Lot Number: 00831G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6FR GUIDING CATHETER