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

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	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, a balloon catheter's hydrophilic coating was observed to be "coming apart." the balloon was set aside and another was used.There was no patient involvement.
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 is currently underway.A supplemental report will be submitted when investigation is completed.
Additional Manufacturer Narrative
The investigation of the returned balloon catheter found the hydrophilic coating peeled on the proximal and distal ends of the balloon, which is consistent with the alleged product issue.Per the ifu, 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, it should not be allowed to dry.The peeling of the coating is consistent with improper hydration/re-hydration of the device during preparation.

• Brand Name: BOBBY 8F
• Common Device Name: PERCUTANEOUS CATHETHER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15655571
• Report Number: 2032493-2022-00417
• Device Sequence Number: 19446669
• Product Code: QJP
• UDI-Device Identifier: 00842429108543
• UDI-Public: (01)00842429108543(11)211130(17)241031(10)0000121975
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/05/2022

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: 10/31/2024
• Device Model Number: BOB-895-US
• Device Lot Number: 0000121975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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