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 11/18/2023

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 at the end of an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 c-ring tubing for the scope wash was pulled out.Per the photo provided by the complainant the scope wsh tubing appeared to be bent but remained attached.The case was completed, so there was no additional device needed.There was no delay, or harm to the patient reported.

Manufacturer Narrative

Tw# (b)(4).The device was returned to the factory for evaluation on 12/19/2023.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood were observed on the cannula tip, jaws, and c-ring.The c-ring was observed to be intact, however the clear plastic scope wash tube connecting the c-ring to the cannula was observed to be bent, but remained connected to the c-ring.The metal arm was observed to be intact with no visual defects.An investigation was conducted on (b)(6) 2024.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.Evidence of charred material was observed between the jaws of the harvesting device.The heater wire and gray silicone insulation of both the hot and cold jaws were observed to be intact with no visual defects.The c-ring was observed to be intact, however the clear plastic scope wash tube connecting the c-ring to the cannula was observed to be bent and disconnected from the based of the c-ring.The metal arm was observed to be intact, with no visual defects.Based on the photographic inspection, returned condition of the device, and investigation results, the reported failure "material twisted/bent; scope wash tubing", as well as the analyzed failure "break; scope-wash tubing", was confirmed.The lot # 3000324397 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
• 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: 18290808
• MDR Text Key: 330043715
• Report Number: 2242352-2023-01007
• Device Sequence Number: 1
• Product Code: GEI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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
• Device Lot Number: 3000324397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 105 KG