MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem No Flow (2991)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500, there was no flow.No injury, customer opened a new kit to complete the case.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25156354 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 returned to the factory for evaluation on 04/20/2021.An investigation was conducted on 05/04/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the cannula.The c-ring was observed to be intact, no visual defects were observed.There were no visual defects observed on the cannula.The scope wash system was evaluated by passing a syringe full of tap water through the scope wash delivery tube.The water exited through the cannula.The c-ring assembly was examined for blockages and breaks in the tubing.No defects of breaks were observed.The c-ring was inspected using microscopy.No visual defects were observed.Based on the returned condition of the device, the reported failure "no flow" was not confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500, there was no flow.No injury, customer opened a new kit to complete the case.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 11780938
• MDR Text Key: 249316401
• Report Number: 2242352-2021-00342
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

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 Expiration Date: 02/12/2022
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 25156354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 05/26/2021
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 97