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

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

(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, vasoviewhempro vh-3500 balloon on the btt wouldn't stay inflated.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, vasoviewhempro vh-3500 balloon on the btt wouldn't stay inflated.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" vh-3500 balloon on the btt wouldn't stay inflated.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 25153154 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 on 12/08/2020.An investigation was conducted on 01/13/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the btt.A mechanical evaluation was conducted.Air was inserted into the silicon balloon and the balloon would not inflate.Bubbles were seen rapidly releasing from the puncture during a bubble emission test in plain water.A tear was observed on the silicone balloon.Based on the returned condition of the device, the reported failure "inflation issue" was confirmed.The c of c was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10835874
• MDR Text Key: 216136463
• Report Number: 2242352-2020-00996
• 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,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 25153154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 103