MAUDE Adverse Event Report: MICROVENTION, INC. BOBBY 8F; CATHETER PERCUTANEOUS

Model Number	BOB-895-US
Medical Device Problem Codes	Flaked (1246); Device Difficult to Setup or Prepare (1487); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned despite attempts made.Additional due diligence attempts are ongoing.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
It was reported that this morning while prepping the bobby for a carotid stent case.The tech found that the balloon had little flecks of material sticking out from the balloon.No patient involvement.
Additional Manufacturer Narrative
Based on our investigation findings there was no coating issue.The device was not being hydrated properly at the time the balloon was attempted to be inflated.Therefore, mvi no longer considers this event a reportable malfunction.

• Brand Name: BOBBY 8F
• 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: 23097133
• Report Number: 2032493-2025-90500
• Device Sequence Number: 15607804
• Product Code: DQY
• UDI-Device Identifier: 00842429108543
• UDI-Public: (01)00842429108543(11)250331(17)280229(10)0001042388
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K193607
• 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): 10/15/2025

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: BOB-895-US
• Device Lot Number: 0001042388
• Was Device Available for Evaluation?: No
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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