MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Fitting Problem (2183)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro vh-3500 bisector would not advance into the harvest cannula.The bisector would continuously get stuck in its channel on the cannula.A new device was opened to complete the procedure.No injury or harm to the patient.

Manufacturer Narrative

Trackwise # (b)(4) updated section: b4, g4, g7, h2, h3, h6, h10 the device was returned to the factory for evaluation on 12/12/2022.An investigation was conducted on 12/14/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The harvesting device was returned partially inside the cannula.A mechanical evaluation was conducted.The harvesting device was removed from the cannula with no physical or visual difficulties observed.A reference endoscope was inserted into the cannula until it snapped into place with no physical or visual difficulties observed.The harvesting device was inserted into the cannula with no physical or visual difficulties observed.The blue toggle was manipulated to extend and retract the c-ring with no physical or visual difficulties observed.The blue toggle was manipulated to open and close the jaw with no visual or physical difficulties observed.Based on the returned condition of the device as well the evaluation results, the reported failure "fitting problem- tool" was not confirmed.The lot # 3000275230 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

N/a.

• Brand Name: VASOVIEWHEMPRO VH-3500
• 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: 16025382
• MDR Text Key: 308447011
• Report Number: 2242352-2022-01030
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 3000275230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1