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

Model Number	VASOVIEW 7 XB BISECTOR (US)
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (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 or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector (us), pa states he has been noticing small shards of plastic come out of the shaft of the device.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise id (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector (us), pa states he has been noticing small shards of plastic come out of the shaft of the device.Same device was used and completed procedure with no other issues.Nothing fall into the patient.The hospital did not report any patient effects.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated sections: g4,g7,h2,h3,h6,h10.Internal complaint number: (b)(4).The device was returned to the factory for evaluation on 01/18/2021.An investigation was conducted on 03/08/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.Blood was observed on the cannula as well as on the harvesting device.The harvesting device was returned inside the cannula.There were no visual defects observed on the harvesting device or the cannula.A white strand of material was also returned for evaluation.A mechanical evaluation was conducted.The harvesting device was removed from the cannula with no physical or visual difficulties.The harvesting device was re-inserted into the cannula with no physical or visual difficulties.No shavings were observed.Based on the returned condition of the device, the reported failure "particulates; shavings" was confirmed.

• Brand Name: VASOVIEW 7 XB BISECTOR (US)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11236205
• Report Number: 2242352-2021-00072
• Device Sequence Number: 3842299
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: VH-3200
• Device Lot Number: 25152645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/08/2021; 06/17/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/05/2021; 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 114