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

Catalog Number	1012270-20
Medical Device Problem Codes	Break (1069); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
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.The nc trek device referenced in b5 is filed under separate a medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat calcified lesions in the middle and distal third right coronary artery (rca).The hi-torque 014 bmw guidewire (gw) was used in the procedure; however, the gw would not allow the advancement of a 2.0 mini trek balloon dilatation catheter (bdc) and a 3.25x20mm nc trek bdc.When attempting to advance each bdc, resistance was met with the gw and the shaft became stretched and broke on each bdc.The gw was exchanged for a hi-torque 014 bhw gw, which was also noted to have difficulty when advancing other devices.Two drug-eluting stents were implanted to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MINI 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: 18164098
• Report Number: 2024168-2023-12852
• Device Sequence Number: 15284233
• Product Code: LOX
• UDI-Device Identifier: 08717648138164
• UDI-Public: 08717648138164
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/12/2023

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: 08/31/2025
• Device Catalogue Number: 1012270-20
• Device Lot Number: 20902G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HI-TORQUE 014 BMW HYDRO 3CM J GUIDEWIRE
• Patient Age: 81 YR
• Patient Sex: Unknown