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

Model Number 1012450-12

Device Problems Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during advancement in the 6fr guiding catheter, the 3.25x12mm nc trek balloon catheter met resistance and the shaft separated.The device was simply removed and the procedure was completed with another device.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation was confirmed; however, the reported difficulty advancing 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 complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9489612
• MDR Text Key: 178117740
• Report Number: 2024168-2019-14690
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151927
• UDI-Public: 08717648151927
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1012450-12
• Device Catalogue Number: 1012450-12
• Device Lot Number: 90817G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6FR GUIDING CATHETER
• Patient Age: 85 YR