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

Model Number	1012276-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a 95% stenosed lesion in the proximal right coronary artery (rca) with moderate calcification and moderate tortuosity.The 2.5x15mm trek balloon dilatation (bdc) was kinked prior to be being advanced through a co-pilot device and the shaft of the bdc broke in half due to error use by the scrub tech.The bdc was not used in the procedure.Then, the 3.5x12mm trek balloon dilatation catheter shaft broke in two pieces during advancement while inside a 6 fr guide liner.Therefore, a an unspecified balloon was advanced to the distal part of the guide liner and then inflated to remove all devices as a single unit.Ballooning and stenting were performed to finish the procedure.There was no patient adverse effects and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation 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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported separation and unexpected medical intervention appears to be related to circumstances of the procedure.There was no damage noted to the balloon dilatation catheter (bdc) during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulty.In this case, it is likely that the device was inadvertently mishandled during preparation and/or advancement, such that the bdc became kinked and upon further manipulation during attempts to advance the device into the guideline the hypotube ultimately separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 21117779
• Report Number: 2024168-2025-00385
• Device Sequence Number: 12941498
• Product Code: LOX
• UDI-Device Identifier: 08717648138560
• UDI-Public: (01)08717648138560(17)270531(10)40614G1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012276-12
• Device Catalogue Number: 1012276-12
• Device Lot Number: 40614G1
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 136 KG