MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-4000

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2023

Event Type  Injury  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 c-ring plastic piece and metal tip broke off inside patient during endoscopic vein harvest.A cutdown was required to retrieve pieces.A new device was used to complete the procedure.Extra time spent retrieving piece and harvesting vein.Additional incisions to retrieve the broken piece because cutdown was required.

Manufacturer Narrative

Tw id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text : device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 c-ring was split in half vertically.The pieces were later noted to be contained within the device and nothing fell into the tunnel.Incident occurred almost at the end of the procedure.It was transected.The distal stab-and-grab incision was extended to around 1¿ to search for any missing components prior to it being noticed that it was still attached to the device.Nothing unusual to report about this particular case.There were not any components of the c-ring assembly engaged with the hemopro 2 jaws during the procedure that was noticed.5 to 10 minutes delay.A new device was used to complete the procedure.The patient vein was not damaged and the patient recovered well without any adverse outcomes.No drain insertion.

Manufacturer Narrative

Trackwise#: (b)(4).Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot#: 3000314870 history record review was completed.There were no 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.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: 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: 17626885
• MDR Text Key: 321989505
• Report Number: 2242352-2023-00720
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000314870
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CAMERA.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 123 KG