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

Model Number 1012451-15

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that while opening the 3.5x15 mm nc trek balloon dilatation catheter (bdc), the shaft broke.The device was not used and there was no patient involvement.There was no clinically significant delay in the procedure.A new nc trek was used to continue the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported break was able to 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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during unpackaging and/or during advancement onto the guide wire/use resulted in the noted device damages (kink, multiple bends) and ultimately resulted in the reported break/separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: patient code 2645 was removed.

Event Description

Additional information: returned device analysis identified that the device was inserted into the anatomy.No additional information was provided.

• 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: 9419681
• MDR Text Key: 177770258
• Report Number: 2024168-2019-14218
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1012451-15
• Device Catalogue Number: 1012451-15
• Device Lot Number: 90930G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1