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

Model Number	VH-3500
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
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
The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 tip of the cautery broke off inside the leg when attempting to ligate a branch.The tip was successfully recovered with an endoscopic grabber with no additional incisions needed.A new device was opened to complete the procedure.There was a procedural delay to retrieve the broken piece and finish the harvest.There was no patient harm.
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 tip of the cautery broke off inside the leg when attempting to ligate a branch.The tip was successfully recovered with an endoscopic grasper with no additional incisions needed.A new device was opened to complete the procedure.There was a procedural delay to retrieve the broken piece and finish the harvest.There was no patient harm.Photos provided by the complainant show the jaws of the device with part of the silicone separated from the jaws.There is evidence of blood.
Additional Manufacturer Narrative
Trackwise id#: 1078649 updated sections: b-4, b-5, d-9,g-3, g-6, h-2, h-3,h-6, h-11 the device was returned to the factory for evaluation on 08/08/2024.A photograph was provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood and charred material were observed.The gray silicone insulation on the tip of the cold jaw was observed to be peeled and detached, exposing the metal tip.No other visual defects were observed.An investigation was conducted on 08/08/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed.The heater wire and gray silicone insulation of the hot jaw were observed to be intact with no visual defects.The insulation on the tip of the cold jaw was observed to be peeled and detached, exposing the metal tip.The detached silicone was not returned for evaluation.Based on the photographic evaluation, returned condition of the device, and investigation results, the reported failure "peeled; delaminated; jaw" was confirmed.The lot # 3000377320 history record review was completed.There was one 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.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.

• Brand Name: VASOVIEW HEMOPRO
• 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 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 19838969
• Report Number: 2242352-2024-00851
• Device Sequence Number: 12454693
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K153194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 03/04/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000377320
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 88 KG