MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK II OTW CORONARY DILATATION CATHETER

Catalog Number	1012402-08A
Medical Device Problem Codes	Product Quality Problem (1506); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 99% stenosed de novo lesion in the 1st diagonal artery with heavy calcification and moderate tortuosity.The 1.5x8mm mini trek balloon dilatation catheter (bdc) was used in the procedure; however, one part of the center marker appeared to be on the tip of the bdc.The bdc was used in the procedure without issue.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported product quality problem and missing component could not be confirmed.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to confirm the reported difficulties; therefore, a conclusive cause cannot be determined.It was reported that the a portion of the balloon dilation catheter¿s (bdc) center balloon marker appeared to be on the tip.Analysis of the returned device was unable to confirm the reported marker movement.There was no damage or anomalies noted to the balloon markers.Additionally, a cine was reviewed and was unable to confirm the reported marker movement.Follow-up with the account confirmed the correct device was returned.In this case, because the reported device issue was unable to be confirmed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MINI TREK II OTW 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: 19334034
• Report Number: 2024168-2024-05970
• Device Sequence Number: 19608560
• Product Code: LOX
• UDI-Device Identifier: 08717648180811
• UDI-Public: (01)08717648180811(17)260930(10)31013G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 09/30/2026
• Device Catalogue Number: 1012402-08A
• Device Lot Number: 31013G1
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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