MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR (US); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEW 7 XB BISECTOR (US)
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector (us), broken/faulty device.No injury.They stated at the beginning of the case they were setting up the equipment and tried to place the scope in the harvesting cannula and it would not advance.When the cannula was inspected, there was a piece of plastic obstructing the inside of the cannula.The device was removed from the case and not used.Patient was in the or; however, the device was not used on the patient.They pulled out a new vasoview kit and completed the procedure as needed.
Additional Manufacturer Narrative
Trackwise (b)(4).Updated section: g4, g7, h2, h3, h6, h10.Analysis of production: (3331/213/67) the device history records review concluded that there were ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213) the overall 24 month complaint trend data for the period nov 2019 through oct 2021 was reviewed.Run rule was triggered for the month of oct 2021.The trigger is addressed under crf 572954.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual: (10/213/67).The device was returned to the factory for evaluation on 10/08/2021.A photograph was provided by the account.Signs of clinical use and no evidence of blood was observed.The photograph showed the inside of the cannula from the bottom of the cannula.There was a piece of white plastic material on the inside of the cannula.No other visual defects were observed.An investigation was conducted on 10/13/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The bisector blade was observed to be intact, no visual defects were observed.A mechanical evaluation was conducted.A reference endoscope was inserted into the cannula with no physical or visual difficulties.The harvesting device was inserted into the cannula with no physical or visual difficulties observed.The toggle switch was manipulated to extend and retract the blade with no physical or visual difficulties.Based on the returned condition of the device, the reported failure "fitting problem" was not confirmed.

• Brand Name: VASOVIEW 7 XB BISECTOR (US)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12681027
• Report Number: 2242352-2021-00855
• Device Sequence Number: 11802465
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 06/14/2023
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: C-VH-3200
• Device Lot Number: 25158829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown