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

Model Number VASOVIEW HEMOPRO 2

Device Problems Inflation Problem (1310); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

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 trocar failed midway through procedure while inflated.Harvester indicated that there was no excessive inflation and that nothing out of the ordinary was experienced during the case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(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, vasoview hemopro 2 trocar failed midway through procedure while inflated.Harvester indicated that there was no excessive inflation and that nothing out of the ordinary was experienced during the case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

H6 correction: patient code changed to code 4582.Internal complaint number: (b)(4).The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 25153749history 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 03/04/2021.An investigation was conducted on 03/15/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the btt.A mechanical investigation was conducted.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.A leak was observed on the side of the silicone balloon.The btt was unable to be inflated.No visual defects were observed on the silicone btt.Based on the condition of the device, the reported failure "no flow" was confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 trocar failed midway through procedure while inflated.Harvester indicated that there was no excessive inflation and that nothing out of the ordinary was experienced during the case.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 trocar failed midway through procedure while inflated.Harvester indicated that there was no excessive inflation and that nothing out of the ordinary was experienced during the case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: g4, g7, h2, h6, h10, h11.H6 correction: problem code changed to 1310.H10 correction: summary has been corrected.Internal complaint number: (b)(4).The device was returned to the factory for evaluation on 03/04/2021.An investigation was conducted on 03/15/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the btt.A mechanical investigation was conducted.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.A leak was observed on the side of the silicone balloon.The btt was unable to be inflated.No visual defects were observed on the silicone btt.Based on the condition of the device, the reported failure "inflation issue" was confirmed.

• 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: 11378689
• MDR Text Key: 233540602
• Report Number: 2242352-2021-00180
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25153749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1