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 03/13/2024

Event Type  malfunction  

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 actually cracked in half and came off.There was no part of the device left in the leg.It was retrieved by disconnecting the device and using the device as a "scissor" to grab the piece and retrieve it.No additional incision.Another device was opened to complete the procedure.Only procedural delay was in opening a new kit and setting it up.No patient effect.

Manufacturer Narrative

Trackwise #: (b)(4).Corrected section : h6 health effect ¿ clinical code from "procedural complications foreign body in patient" to "others no clinical signs symptoms or conditions" corrected section: b1, b2 changed to product problem based on new information received corrected section: h1 changed to malfunction corrected section: h6 code 4641 was removed.The lot # 3000354208 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.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 c-ring actually cracked in half and came off.Nothing fell into the tunnel or detached from the device.There was no conduit damage, need for another incision, or resultant bleeding.The procedural delay time was around 5 minutes due to opening and switching to a new kit.No patient effect.

• 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: 19032802
• MDR Text Key: 339249346
• Report Number: 2242352-2024-00330
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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: 3000354208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/20/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention