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

Model Number	1012452-12
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10548933
• Report Number: 2024168-2020-07808
• Device Sequence Number: 19616731
• Product Code: LOX
• UDI-Device Identifier: 08717648152023
• UDI-Public: 08717648152023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1