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

Model Number	1012447-12
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the packaging appeared intact; however, upon opening the 2.50 x 12mm nc trek rx balloon dilatation catheter (bdc), a 2.5 x 15mm nc trek bdc was in the hoop.The device was not used, there was no patient involvement and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported complaint was confirmed.Upon investigation, it was determined that the respective lots were manufactured approximately one month apart and in different production lines at the abbott vascular costa rica production site, which indicates the two units involved in this complaint never came into contact with one another during production.Additionally, a query of the system indicated that both lots were sold to the account.All currently available evidence points to the placement of the 2.50x15 mm nc trek bdc in the chipboard box for a 2.50x12 mm nc trek bdc having occurred at the hospital.In this case, it is possible that the 2.50x15 mm nc trek bdc was inadvertently placed in the wrong chipboard box after being pulled for a different procedure, but not used.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 determined the reported complaint 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.E1: title of initial reported.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13973200
• Report Number: 2024168-2022-03450
• Device Sequence Number: 20035069
• Product Code: LOX
• UDI-Device Identifier: 08717648151750
• UDI-Public: 08717648151750
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 10/31/2024
• Device Model Number: 1012447-12
• Device Catalogue Number: 1012447-12
• Device Lot Number: 11124G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown