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

Model Number	VASOVIEW 7 XB BISECTOR (OUS)
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector (ous).The user discovered 1 white fragment by looking at the camera display.The white fragment was found inside patient's leg, and they used tools to remove (details not sure).No additional interventions are required and patient's condition was good.They took out the fragments and finished the procedure using the same vv7.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The 7xb device was not returned for evaluation.However, the white strand material was returned to the factory for evaluation on 01/05/2021 an investigation was conducted on 01/13/2021.A photograph was provided by the account.A photographic inspection was conducted.A white strand of material was observed.A visual inspection was conducted.The 7 xb was not returned for evaluation.A white strand of material was returned.Based on the non- returned of the device, we are unable to determine where the white strand of material may have come from, however, the reported failure "particulates; shavings" was confirmed.The lot#: 25153152 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.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector (ous).The user discovered 1 white fragment by looking at the camera display.The white fragment was found inside patient's leg, and they used tools to remove (details not sure).No additional interventions are required and patient's condition was good.They took out the fragments and finished the procedure using the same vv7.The hospital did not report any patient effects.

• Brand Name: VASOVIEW 7 XB BISECTOR (OUS)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10982864
• Report Number: 2242352-2020-01089
• Device Sequence Number: 3234440
• Product Code: GEI
• UDI-Device Identifier: 00607567700437
• UDI-Public: 00607567700437
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: VASOVIEW 7 XB BISECTOR (OUS)
• Device Catalogue Number: C-VH-3200-W
• Device Lot Number: 25153152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention