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

Model Number	1012403-06A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
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 preparation, the 2.00x6mm mini trek ii over the wire (otw) balloon dilatation catheter (bdc) was found with a hole in the balloon wall.There was no noted damage to the outer packaging.The device was not used in the patient.There was no patient involvement and no clinically significant delay in the procedure.Another 2.00x6mm mini trek ii bdc was used for the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not retuned for evaluation.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 was unable to determine a conclusive cause for the reported complaint.However, possible factors that could contribute to a hole in the balloon include, but are not limited to, balloon damage during processing of the balloon material, inflation technique and insufficient preparation.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 16677611
• Report Number: 2024168-2023-03469
• Device Sequence Number: 5378301
• Product Code: LOX
• UDI-Device Identifier: 08717648180859
• UDI-Public: 08717648180859
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 12/31/2024
• Device Model Number: 1012403-06A
• Device Catalogue Number: 1012403-06A
• Device Lot Number: 20120G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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