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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector (ous), the short port blunt tip trocar (btt) was discovered to be cracked when opened the vv7.They opened another unit of vv7 and finished the surgery.No patient involvement.
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.
Additional Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Trackwise id#: (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting(ous), the short port blunt tip trocar (btt) was discovered to be cracked when opened the vv7.They opened another unit of vv7 and finished the surgery.No patient involvement.
Additional Manufacturer Narrative
Trackwise # (b)(4).The lot # 25158845 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 for evaluation on 06/16/2022.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed.A crack was observed on the inside of the gray endoscope seal.No other visual defects were observed.An investigation was conducted on 07/20/2022.Signs of clinical use and no evidence of blood was observed.There was a crack observed on the inside of the gray endoscope seal.No other visual defects were observed.Based on the photographic inspection as well as the investigation results, the reported failure "crack" was confirmed.For the reported failure "crack" the root cause is undetermined because the event occurred during the use of the device and the procedural operation is unavailable for our review.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

• 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 13673689
• Report Number: 2242352-2022-00194
• Device Sequence Number: 5302812
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2022

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: 06/14/2023
• Device Model Number: VASOVIEW 7 XB BISECTOR (OUS)
• Device Catalogue Number: VH-3200-W
• Device Lot Number: 25158845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 08/08/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 07/06/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown