MAUDE Adverse Event Report: ABBOTT VASCULAR INC. TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012274-20
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during the procedural preparation the chipboard box was labeled as a 3.0x20mm nc trek balloon dilatation catheter (bdc) (part 1012274-20 lot 40417g1); however it was noted that the device within the package did not match what was labeled on the box.The device within the package was noted to be a 3.0x20mm nc trek neo (part 1400300-20 / lot 31007g1) instead of a nc trek.Another nc trek bdc was used and the procedure was completed.No additional information has been provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported complaint was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The investigation determined the reported complaint appears to be related to operational context.All currently available evidence points to the placement of the nc trek neo 3.0mm x 20mm in the chipboard box for a trek 3.0mm x 20mm having occurred at the hospital.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device as the respective lots were manufactured approximately six months apart and on two different manufacturing lines which indicates the two units involved in this complaint never came into contact with one another during production.
Event or Problem Description
It was reported that during the procedural preparation the chipboard box was labeled as a 3.0x20mm nc trek balloon dilatation catheter (bdc) (part 1012274-20 lot 40417g1); however it was noted that the device within the package did not match what was labeled on the box.The device within the package was noted to be a 3.0x20mm nc trek neo (part 1400300-20 / lot 31007g1) instead of a nc trek.Another nc trek bdc was used and the procedure was completed.Subsequent to filing the initial report, update to the event description changing nc trek to trek: it was reported that during the procedural preparation the chipboard box was labeled as a 3.0x20mm trek balloon dilatation catheter (bdc) (part 1012274-20 lot 40417g1); however, it was noted that the device within the package did not match what was labeled on the box.The device within the package was noted to be a 3.0x20mm nc trek neo (part 1400300-20 / lot 31007g1) instead of a trek.Another trek bdc was used and the procedure was completed.No additional information has been provided.

• Brand Name: TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20975762
• Report Number: 2024168-2024-15019
• Device Sequence Number: 8447049
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: (01)08717648138447(17)270331(10)40417G1
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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 Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 40417G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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