MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO 2 W/VASOSHIELD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4001
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 (w/vasoshield) was separated of the metal piece from the jaws.They said it was probably user error because when they were handed the device, it was already put together by a new tech that was there who didn't know that you had to have the jaws up during insertion and preferably the scope in the harvesting cannula as well.They opened another kit to complete the case with no other issues.2-3 minute delay to open up another kit and proceed with case.No harm.
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
N/a.
Additional Manufacturer Narrative
Tw#: (b)(4).Corrected section: d4 udi#.The device was returned to the factory for evaluation on 09/19/2024.An investigation was conducted on 10/09/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.There were no visual defects were observed on the intact cannula or intact c-ring.The shaft of the device closest to the tip of the device was observed to be bent.The heater wire was observed to be flexed and bent away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.There were no visual defects observed on the intact silicone insulation on both the cold and hot jaws.No additional testing was conducted due to the condition of the shaft as well as the heater wire.Based on the returned condition of the device as well as the evaluation results, the reported failure "material twisted/ bent wire" was confirmed as well as the analyzed failure "material twisted/bent shaft" was observed.The lot#: 3000395049 history record review was completed.There is 1 ncmr; 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 or the analyzed failure.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.

• Brand Name: HEMOPRO 2 W/VASOSHIELD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 20334355
• Report Number: 2242352-2024-0001075
• Device Sequence Number: 8004222
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000395049(17)260517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 05/17/2026
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 3000395049
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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