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

Model Number	VH-3200-W
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw 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
Hospital reported vasoview 7 xb bisector (ous) gas flow had an issue whereby the gas was not able to flow.They troubleshooted by changing another insufflator machine but still no flow.Subsequently, change another set and surgery went smoothly.
Event or Problem Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview 7 xb bisector (ous) gas flow had an issue whereby the gas was not able to flow through the cannula.They troubleshooted by changing another insufflator machine but still no flow.Subsequently, change another set and surgery went smoothly.There was a delay.No harm.
Additional Manufacturer Narrative
Trackwise #: (b)(4).
Additional Manufacturer Narrative
Trackwise id#: (b)(4).The device was returned to the factory for evaluation on 07/29/2024.An investigation was conducted on 07/31/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact harvesting device or intact cannula.The device was evaluated for the presence or absence of air flow through the distal insufflation tube using a cannula with the help of calibrated uson (id 14332).A reference endoscope was inserted into the complaint device and evaluated for air flow.The device passed the air flow test, the co2 insufflation path on the complaint unit was open and unobstructed.The value displayed was 2155 sccm, which is within the specified acceptable range of 2000sccm-4500sccm (mpi2051005 rev.Aq step 9).Based on the condition of the device, the reported failure "improper flow or infusion" was not confirmed.The lot # 3000346359 history record review was completed.There was one (01) ncmr , rework, or deviations documented for the reported lot number.[ncmr # (b)(4)- environmental excursion (low temperature) on whse incubator tag# (b)(4)for 38 minutes.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW 7 XB, 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: 19139519
• Report Number: 2242352-2024-00391
• Device Sequence Number: 12873006
• Product Code: GEI
• UDI-Device Identifier: 00607567700437
• UDI-Public: 00607567700437
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 10/08/2025
• Device Model Number: VH-3200-W
• Device Catalogue Number: VH-3200-W
• Device Lot Number: 3000346359
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 04/22/2024; 08/06/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/13/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown