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

Model Number	1012274-12
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Separation (1562); Component Missing (2306); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
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 the procedure was to treat a lesion in the hepatic artery.When the 3x12mm trek balloon dilatation catheter (bdc) was opened, the flushing tool was noted to not be in the packaging.The bdc was advanced with resistance with the guide wire (gw); therefore, the bdc was removed and resistance was also noted.After removal, the balloon of the bdc was noted to have moved on the delivery system, as if the balloon partially detached (broke).Another trek balloon was used to continue 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.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 information provided, a definitive cause for the reported difficulty advancing and removing the device from the guide wire and component missing could not be determined; however, the reported separation appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 - device available for evaluation updated from yes to no.
Event or Problem Description
Subsequent to the it initial report being filed, it was reported that the 3x12mm trek balloon did not separate completely from the delivery system; however, the balloon had became detached from where the balloon was mounted on the delivery system.No additional information was provided.

• 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: 21970137
• Report Number: 2024168-2025-04717
• Device Sequence Number: 8436638
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: (01)08717648138423(17)280131(10)50221G1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180040
• 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): 06/11/2025

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 Model Number: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 50221G1
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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