MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW EVH ACCSESSORY PACK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vv 6 accessory pack balloon on the btt popped.A new kit was opened to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Tw id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vv 6 accessory pack balloon on the btt popped.A new kit was opened to complete the procedure.Only delay was to open a new kit.There was no patient injury.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Updated sections: b4, b5, d10, e1, g4, g7, h2, h6, h10.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 11/30/2023.An investigation was conducted on 12/05/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the intact btt body.There was a slit observed on the side of the btt silicone balloon.No other visual defects were observed.A mechanical evaluation was conducted.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.A leak were observed on the silicone balloon.The btt was unable to be inflated.Based on the returned condition of the device, and the investigation results, the reported failure "material rupture " was confirmed.A ship history was performed to the account, there is no evidence that anything was shipped to the account prior to the aware date.

• Brand Name: VASOVIEW EVH ACCSESSORY PACK
• 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: 18183177
• Report Number: 2242352-2023-00956
• Device Sequence Number: 15345393
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: 00607567700376
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2024

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 Model Number: VH-2004
• Device Catalogue Number: VH-2004
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 01/10/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/12/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown