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

Model Number VH-4000

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 tip of the jaw fell off the skewer during the procedure.The clamping jaws metal heating wire are broken in the removal tool.The metal heating wire came loose and came out of the silicone.After a single correction, the great saphenous vein could be prepared to the end.However, at the end the tip of the current fell off the plastic cap again.Per photos provided by the complainant, the heater wire is detached from the jaw.There were no complications during the operation and no consequences after the operation.Procedure completed with the same device.There was a brief delay by trying to press the metal tip back onto the jaws.No harm was caused to patients.

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.E1 event site name due to (b)(6) hospital.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 04/12/2024.Photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact clear silicone insulation on both the hot and cold jaws.The heater wire was observed to be flexed away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.No other visual defects were observed.An investigation was conducted on 04/17/2024.Both the harvesting device as well as the cannula was returned for evaluation.Signs of clinical use and evidence of blood was observed on both devices.There were no visual defects observed on the intact cannula or intact c-ring.There were no visual defects observed on the intact clear silicone insulation on both the cold and hot jaws.The heater wire was observed to be flexed away from the hot jaw from the base of the hot jaw with detachment of the heater wire at the tip of the hot jaw.No other visual defects were observed.No electrical testing was conducted due to the condition of the heater wire.Based on the photographic evaluation as well as the returned condition of the device, the reported failure "material twisted/ bent wire" was confirmed.The lot # 3000353125 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: 19050694
• MDR Text Key: 339880591
• Report Number: 2242352-2024-00339
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000353125
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 11/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 69 KG