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

Model Number	1012274-20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2025
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.
Event or Problem Description
It was reported that the procedure was treat a heavily calcified, mildly tortuous, with restenosis of an unspecified previously implanted stent.Sequential angioplasty was performed with a 1.5x15mm trek balloon, 3.0x20mm trek balloon and a 3.5x20mm nc trek balloon catheters to 20 atmospheres.Then angioplasty was performed with a 3.5x20mm non-abbott drug eluting balloon catheter at 20 atmospheres.Control angiography showed recoil of up 80%.Balloon angioplasty was performed with 3.0x20mm trek balloon at 16 atmospheres for 20 seconds.During removal the distal tip separated and after numerous attempts to remove the separated portion via snare it was unsuccessful as tip remain stuck.It was confirm with angiography that there is satisfactory blood flow, no dissections or distal embolism.The patient was discharged.No clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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.A cine was received and reviewed by an abbott vascular clinical specialist.The report indicates that due to the limited and poor quality of the angiograms provided, it is not possible to determine with certainty if the tip of a balloon catheter was fractured and separated and retained in the rca.Based on the information provided, a definitive cause for the reported separation could not be determined; however, the reported unexpected medical intervention and foreign body in patient appear to be related to circumstances of the procedure.Possible factors that may contribute to tip separation may include, but not limited to, manufacturing damage, interaction with the guide wire, interaction with the anatomy, user attempts to remove against resistance and physician applies excessive force against resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.G4 correction: pma/510(k) number updated.
Event or Problem Description
N/a.

• 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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22863338
• Report Number: 2024168-2025-08821
• Device Sequence Number: 9404178
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: (01)08717648138447(17)270228(10)40305G1
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 40305G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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 Sex: Unknown