MAUDE Adverse Event Report: MICROVENTION, INC. BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number	BC0210M-US
Medical Device Problem Codes	Entrapment of Device (1212); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part / lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for analysis and the investigation ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that the physician embolized with onyx.After embolizing for 20-30 minutes, the procedure was done and the physician tried to remove the catheter after deflating the balloon.The catheter appeared stuck to the onyx.The physician pulled back with gentle pressure and locked the touey down.The physician did this a couple of times and then the catheter broke.They were able to go in with a snare and remove the part of the catheter left behind, verifying that nothing was left inside the patient before closing.There was no patient injury, and condition remained unchanged.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned balloon microcatheter found the shaft broken proximal to balloon section of the device with the guidewire lumen stretched and damaged, which is consistent with the broken condition described in the reported event.However, no damage to the balloon membrane was observed and no onyx was observed on the exterior of the distal end of the device; therefore, the investigation could not verify that the device experienced the entrapment described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the shaft damage, but the damage is consistent with the device experiencing tensile forces that exceeded the strength of the catheter shaft.
Event or Problem Description
Please see section h11 for device investigation results.

• Brand Name: BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 23735554
• Report Number: 2032493-2025-90693
• Device Sequence Number: 10562081
• Product Code: DQY
• UDI-Device Identifier: 00842429106563
• UDI-Public: (01)00842429106563(11)250528(17)280430(10)0001089974
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: BC0210M-US
• Device Lot Number: 0001089974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown