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

Model Number VASOVIEW HEMOPRO 2

Device Problems Inability to Irrigate (1337); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

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 chanel for dispensing saline to clean the endoscope was not operable.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 chanel for dispensing saline to clean the endoscope was not operable.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: d10, g4, g7, h2, h3, h6, h10.Corrected sections: h4 - changed category # to 4001; h6 - changed device code to inability to irrigate.Trackwise # (b)(4).The device was returned to the factory on 02/18/2020.An investigation was conducted on 02/27/2020.The harvesting device was returned inside the cannula.The harvesting device was removed from the cannula with no visual defects observed.Signs of clinical use and heavy amounts of blood and tissue were observed on intact c-ring.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 "inability to irrigate" was not confirmed.A lot history record review was completed for lots 25145830, 25146287, and 25146721 the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9601503
• MDR Text Key: 186296278
• Report Number: 2242352-2020-00067
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• 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: 03/02/2020

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: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1