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 03/04/2024

Event Type  malfunction  

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.

Event Description

The hospital reported that vasoview hemopro 2 metal wire came apart from the jaws.The jaws weren't open upon insertion into the cannula.Nothing broke off into the patient and there was a procedural delay while they opened a new kit to finish the case.No patient harm was reported.

Manufacturer Narrative

Trackwise #: (b)(4).The lot # 3000361985 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.The device was not returned to maquet cardiac surgery for investigation; however, a photograph was provided by the account.A photographic evaluation was conducted.Signs of clincial use and evidence of charred material was observed on the heater wire.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 at the tip of the hot jaw.No other visual defects were observed.Based on the non-return of the device as well as the photographic evaluation, the reported failure "material twisted/ bent wire" was confirmed.

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: 18958856
• MDR Text Key: 338352107
• Report Number: 2242352-2024-00282
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: 3000361985
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 126 KG