MAUDE Adverse Event Report: MICROVENTION, INC. BOBBY 8F; ISCHEMIC STROKE

Model Number	BOB-895-US
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bobby was inflated prior to use and was observed to have material sticking out from the balloon.The balloon was not used in the patient.No patient harm or injury occurred.
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.
Additional Manufacturer Narrative
Items received for investigation: bobby 8f (2 bobby units were returned) items not received for investigation: n/a the second device referenced- mdr ref.No.: 2032493-2023-00903 ; mvi ref.No (b)(4).Two bobby units of the same material number were returned for evaluation unlabeled and in the same packaging; therefore, they will be referred to as units 1 and 2 during this investigation for clarity.Unit 1 was returned deflated, and the coating appeared intact.Unit 2 was returned deflated and had visible damage to the surface coating.For functional testing during the investigation, unit 1 was hydrated in saline and inflated without any damage to the surface coating.Unit 2 was hydrated in saline and inflated; there was visible peeling of the surface coating, consistent with the damage observed in its deflated state.Both of the customer-provided images appeared to be of the same device and are consistent with the damage observed on unit 2.Per the ifu100050 precautions, the balloon guide catheter has a lubricious surface and should be hydrated in saline solution for at least 10 seconds prior to use.Once the balloon guide catheter is hydrated, do not allow it to dry.
Event or Problem Description
See h10.

• Brand Name: BOBBY 8F
• Common Device Name: ISCHEMIC STROKE
• 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: 17561270
• Report Number: 2032493-2023-00907
• Device Sequence Number: 6854869
• Product Code: QJP
• UDI-Device Identifier: 00842429108543
• UDI-Public: (01)00842429108543(11)220519(17)250430(10)0000189864
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 04/30/2025
• Device Model Number: BOB-895-US
• Device Lot Number: 0000189864
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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: Other
• Patient Sex: Unknown