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

Model Number VH-3500

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

Tw 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.Due to character limitations e1- event site name: (b)(6) health care.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 c ring on the cannula washer tube was not attached.A new device was opened to complete the procedure.The damaged device was never used on the patient.

Manufacturer Narrative

Trackwise#: (b)(4).Corrected sections: h6--medical device ¿ problem code corrected from code "2981" to "2907".The device was returned to the factory for evaluation on 03/04/2024.An investigation was conducted on 03/05/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact cannula handle.The c-ring was observed to be intact with no visual defects observed.The metal arm of the c-ring was observed to be intact with no visual defects observed.The plastic arm of the c-ring was observed to bent slightly with a visual difference observed.No other visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "detachment of device or device component" was not confirmed, however the analyzed failure "material twisted/bent scope wash " was observed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000361036 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.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 washer tube was damaged on device.The tube that connects the washer to the c-ring was not attached.A new device was opened to complete the procedure.The damaged device was never used on the patient.

• Brand Name: VASOVIEW HEMOPRO
• Type of Device: 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: 18852557
• MDR Text Key: 337201369
• Report Number: 2242352-2024-00196
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000361036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1