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

Model Number VH-4000

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The hospital reported that vasoview hemopro 2 jaws fell apart.

Manufacturer Narrative

E1 event site name exceeded character limitations: (b)(6).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.

Manufacturer Narrative

Trackwise #: (b)(4).Updated sections: b-4 ,g-3, g-6, h-2, h-3,h-6, h-10.Corrected section e3 "occupation" the lot # 3000365389 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.H3 other text : device not returned.

Event Description

N/a.

Manufacturer Narrative

Trackwise #: (b)(4).Corrected section : 4114 and 3221 have been removed.The device was returned to the factory for evaluation on 04/25/2024.An investigation was conducted on 05/01/2024.Signs of clinical use and evidence of blood and charred material were observed.The heater wire and clear silicone insulation of the jaws were observed to be intact with no visual defects.Charred material was observed between the jaws and on the heater wire, however there were no signs of deterioration on the jaws.The accessories, cannula, and c-ring were observed to be intact with no visual defects.The returned material was observed to be charred tissue and blood.Based on the investigation results, returned condition of the device, and the no specific failure reported, there were no defects observed with the device.

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: 18920673
• MDR Text Key: 337857782
• Report Number: 2242352-2024-00252
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3000365389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/25/2024; 05/03/2024
• Supplement Dates FDA Received: 04/25/2024; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Prefer Not To Disclose