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

Model Number	SF6131-B895-US
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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.Investigation found a damaged section under the strain relief that contributed to the difficulties seen throughout the inflation process, consistent with the alleged product issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that the balloon guide catheter was used in a thrombectomy procedure up the left internal carotid artery (ica) and was passed through for aspiration.Upon balloon deflation, the balloon slightly deflated then would not deflate anymore and physician started pulling back bubbles immediately on syringe.The balloon was deflated enough to pull back into an 8fr sheath and once entered into the sheath, the balloon deflated immediately.Reportedly, the patient had severe iliac tortuosity.Thrombectomy was successful and there was no report of harm or injury to the patient.

• Brand Name: BOBBY
• Common Device Name: BALLOON GUIDE CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12668740
• Report Number: 2032493-2021-00420
• Device Sequence Number: 19134537
• Product Code: QJP
• UDI-Device Identifier: 00842429108574
• UDI-Public: (01)00842429108574(11)210318(17)240229(10)210318138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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 Expiration Date: 02/29/2024
• Device Model Number: SF6131-B895-US
• Device Lot Number: 210318138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1