MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR (US); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW 7 XB BISECTOR (US)

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

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 preparation for an endoscopic vein harvesting procedure, using vasoview 7 xb bisector (us).They called and said one of their vh-3200 was opened - when box was opened for procedure to use 1 each vh-3200 for surgery, the plastic bag the product was in was opened, it had a hole in package, customer deemed product unsterile.A replacement device was used to complete the procedure.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, using vasoview 7 xb bisector (us).They called and said one of their vh-3200 was opened - when box was opened for procedure to use 1 each vh-3200 for surgery, the plastic bag the product was in was opened, it had a hole in package, customer deemed product unsterile.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

Trackwise id # (b)(4).The lot # 25151774 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 12/30/2020.An investigation was conducted on 01/22/2021.A visual inspection was conducted.No signs of clinical use or evidence of blood was observed as the device was returned in its protective outer wrapping inside the plastic protective shell.The protective outer wrapping was observed to be closed on all sides.However, on the back of the protective outer wrapping a pinhole was observed.There were no other visual defects observed.Based on the returned condition of the device, the reported failure "manufacturing or shipping issue associated with device" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.

• Brand Name: VASOVIEW 7 XB BISECTOR (US)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11027516
• MDR Text Key: 222040708
• Report Number: 2242352-2020-01118
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (y/n): N
• PMA/PMN Number: K041981
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: C-VH-3200
• Device Lot Number: 25151774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1