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

Model Number 1012452-12

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an nc trek box with the outer labeling of 3.75x12mm contained an nc trek balloon with the inner labeling of a 3x15mm nc trek.The device was not used and there was no patient involvement.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The reported device markings / labelling problem 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a mix-up of device packaging occurred at the hospital.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: NC TREK RX & VOYAGER NC
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10548933
• MDR Text Key: 207535902
• Report Number: 2024168-2020-07808
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152023
• UDI-Public: 08717648152023
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1012452-12
• Device Catalogue Number: 1012452-12
• Device Lot Number: 80511G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1