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

Model Number 1012449-15

Device Problems Inflation Problem (1310); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

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.

Event Description

It was reported that the procedure was performed to treat a lesion with mild calcification in the left anterior descending artery.A 3.0 x 15mm nc trek balloon dilatation catheter (bdc) was advanced without any resistance and the balloon crossed the target lesion.However, the balloon failed to inflate during the first inflation.The unspecified indeflator was changed, thinking the indeflator was the cause but the balloon would still not inflate.Therefore, the bdc was retracted to be removed.Although there was no resistance, the mid shaft became separated during removal.The separated portion was withdrawn with the guide wire as a single unit.The patient was stable and the procedure was continued with an unspecified balloon.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported inflation issue could not be confirmed.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 inflation issue; however, the reported separation 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 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: 10987892
• MDR Text Key: 220902402
• Report Number: 2024168-2020-10399
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151873
• UDI-Public: 08717648151873
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1012449-15
• Device Catalogue Number: 1012449-15
• Device Lot Number: 00926G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 88