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

Model Number	1012279-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 performed to treat a lesion in the right coronary artery.After a stent was deployed at the target lesion, a 4.5x12mm nc trek balloon dilatation catheter was used for post dilatation and inflated twice to 9atm and 12atm; however, after the balloon was fully deflated, the balloon was noted to separate in the vessel during removal.The separated balloon was removed by utilizing a guideliner and another trek balloon to trap the dislodged balloon into the guideliner where it was removed from the patient.There was no adverse patient sequela nor clinical delay reported.No additional information was provided.
Additional Manufacturer Narrative
A 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 device analysis, a definitive cause for the reported separation could not be determined.Possible factors that may contribute to a separation may include, but not limited to, interaction with the anatomy, user attempts to remove against resistance and physician applies excessive force against resistance.There was no damage noted to the device during the inspection prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Returned device analysis confirmed the outer and inner member were separated proximally from the distal catheter tip.The separation end of both outer and inner member was circular and torn which suggests that the separation may be related to tensile overload (material stress/fatigue).Based on the returned device, the noted condition at the separation is indicative of difficulty and/or inadvertent mishandling of the device which likely led to the reported separation; however, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: describe event or problem updated.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery.After a stent was deployed at the target lesion, a 4.5x12mm nc trek balloon dilatation catheter was used for post dilatation and inflated twice to 9atm and 12atm; however after the balloon was fully deflated, the balloon was noted to separate in the vessel during removal.The separated balloon was removed by utilizing a guideliner and another trek balloon to trap the dislodged balloon into the guideliner where it was removed from the patient.There was no adverse patient sequela nor clinical delay reported.Subsequent to the initially filed report, the device was received and the analysis revealed that the balloon was wrinkled and bunched but intact, and the distal shaft was noted to be separated.The account confirmed that the original information was misreported and the shaft was noted to separate not the balloon.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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21248497
• Report Number: 2024168-2025-00937
• Device Sequence Number: 18421315
• Product Code: LOX
• UDI-Device Identifier: 08717648138751
• UDI-Public: (01)08717648138751(17)270531(10)40605G1
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 02/25/2025

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: 1012279-12
• Device Catalogue Number: 1012279-12
• Device Lot Number: 40605G1
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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