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

Model Number VASOVIEW HEMOPRO 2

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id #(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 using vasoview hemopro 2.No co2 pressure build-up above the sampling cannula via distal co2 insuflation connection.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.No co2 pressure build-up above the sampling cannula via distal co2 insuflation connection.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: g4,g7,h2,h3,h6,h10.Internal complaint number: (b)(4).The device was returned to the factory on 04/14/2020.An investigation was conducted on 05/28/2020.Signs of clinical use and slight evidence of blood was observed on the inside of the intact c-ring.The cannula was observed to be intact, no visual defects were observed.The insufflation tube and the water tube were observed to be intact.The c-ring appears to have been slightly tainted with blood as it appears to be reddish in color.The c-ring has no visible defects.Air flow on btt was tested on the btt insufflation port and air flow was not obstructed.The device was evaluated for the presence or absence of air flow through the distal insufflation tube using a cannula with the help of calibrated uson.A reference endoscope was inserted into a reference vv7 cannula and an air supply was connected to the distal insufflation tubing luer fitting.Air was passed through the insufflation port and was observed to flow freely through the distal port.To verify this, a pouch was sealed over the distal tip of the cannula.Air was passed through the cannula and the pouch was inflated.The air supply was stopped and the pouch stayed inflated.When gentle pressure was applied to the inflated pouch, the pouch deflated slightly, the air was turned back on and the pouch re-inflated.The test was then repeated for the reported cannula.The reference endoscope was inserted into the complaint device and evaluated for air flow.The device passed the air flow test, the co2 insufflation path on the complaint unit was open and unobstructed.The values displayed were within specified acceptable range which is 2197 sccm.Based upon the returned condition of the device and the results of the investigation, the reported failure "improper flow or infusion" was not confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.No co2 pressure build-up above the sampling cannula via distal co2 insuflation connection.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 9847281
• MDR Text Key: 185295394
• Report Number: 2242352-2020-00261
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Device Lot Number: 25148415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 105