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

Model Number	BOB-895-US
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
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 it has not yet been returned.Medical images were provided.The investigation is currently ongoing.Once the investigation is completed, a supplemental report will be submitted.
Event or Problem Description
It was reported that during preparation, the physician noticed a foreign material was sticking outside of the balloon.No patient involvement.
Additional Manufacturer Narrative
Correction: the original mfr report #: 2032493-2023-00446 is wrong.The correct mfr report number for this report is 2032493-2023-00020.The reported complaint is confirmed.The investigation of the returned balloon catheter found the device kinked at approximately 100cm from the proximal end of the hub and the balloon surface with a flaked/peeled substance, which is consistent with the condition described in the reported event and as observed in the customer-provided images.Ftir analysis of the flaked substance found that it contained materials not used in the balloon or coating; however, multiple ftir measurements needed to be performed on the flaking substance due to the limited quantity available, which may have affected the overall determination.Additionally, two in-house bobby units were tested for inflation without hydrating the balloon, and it was found that the coating did begin to peel and resulted in a similar condition as the returned device.Therefore, while the ftir results were inconclusive, the flaking/peeled coating condition is consistent with the balloon not being hydrated properly at the time the balloon was attempted to be inflated.The physical evaluation of the device could not identify the conditions or circumstances that led to the kink, but the kink is consistent with the device experiencing forces over-specification.The instructions for use (ifu) precautions that 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 h.10.
Additional Manufacturer Narrative
Correction : the original mfr report #: is wrong.The correct mfr report number for this report is 2032493-2023- 00020.

• Brand Name: BOBBY 8F
• Common Device Name: PERCUTANEOUS CATHETHER
• 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: 16107926
• Report Number: 2032493-2023-00446
• Device Sequence Number: 7654223
• Product Code: QJP
• UDI-Device Identifier: 00842429108543
• UDI-Public: (01)00842429108543(11)220322(17)250228(10)0000167784
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2022

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: 02/28/2025
• Device Model Number: BOB-895-US
• Device Lot Number: 0000167784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 12/21/2022; 05/11/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/18/2023; 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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
• Patient Sex: Unknown