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

Model Number VASOVIEW HEMOPRO 2

Device Problems Break (1069); Insufficient Information (3190)

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

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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 Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 failed.No reported injury.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 failed.The c-ring was broken.Polyfuse was not in effect.No procedural delay.A replacement device was used to complete the procedure.No reported injury.

Manufacturer Narrative

Tw# (b)(4).Corrected section- h6 problem code changed to 1069.

Manufacturer Narrative

Trackwise # (b)(4) updated section: b4, g4, g7, h2, h3, h6, h10 the device was returned to the factory for evaluation on 12/21/2022.An investigation was conducted on 12/27/2022.A visual inspection was conducted.The product was returned in a small outer box and the product packaging was observed to be bent to fit inside the outer box.The black shaft of the harvesting device was observed to be bent when removed from the packaging.Signs of clinical use and evidence of blood were observed on the device.Charred material was also observed between the jaws.The c-ring was observed to be cut in half down the center with signs of melting near the flanking curved areas.The scope wash tubing and retention rib remained attached to the cannula.The scope wash tubing and the c-ring remained attached to the cannula due the presence of a retention rib.The heater wire and clear silicone insulation of the jaws were observed to be intact with no visual defects.Based on the returned condition of the device and the evaluation results, the reported failure "break; c-ring", as well as the analyzed failure "material twisted/bent; shaft" was confirmed.The lot #3000242861 history record review was completed.There were ncmrs, rework, or deviations documented for the reported lot number.On (b)(6) 2022, the compressed air system failed and needed to be repaired.The repair and qualification for production took more than one day to be completed.The testing requiring compressed air could not be completed in the required time.Therefore, the following products were included in this ncmr for evaluation: c-vh-2400, batch# 3000241814, cv000007540, batch# 3000242829, c-vh-4000, batch# 3000242861.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 failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.

Event Description

N/a.

• 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: 15932787
• MDR Text Key: 307903752
• Report Number: 2242352-2022-01000
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000242861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1