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

Model Number VH-3500

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

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.

Event Description

The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 wire within the cautery jaws separated from the jaw.The tool was oriented tips up when inserted into the cannula as trained.Another vh-3500 was opened to successfully complete the procedure.There was no significant time delay, just a few minutes to open another kit.There was no patient injury.

Event Description

N/a.

Manufacturer Narrative

Trackwise #: (b)(4).Updated sections: b-4, g-3, g-6, h-2, h-6, h-10.A lot history record review was completed for lots 3000369005, 3000369645, and 3000367542 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.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
• 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: 19050480
• MDR Text Key: 339675997
• Report Number: 2242352-2024-00338
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 96 YR
• Patient Sex: Male
• Patient Weight: 82 KG