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

Model Number VH-4000

Device Problem Mechanical Problem (1384)

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

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

Tw id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text: device discarded.

Event Description

The hospital reported that during an endoscopic radial artery vein harvesting procedure, vasoview hemopro 2 vein guide c-ring (curved u-shaped plastic piece) on the device was noticeably flattened at its base, more flat" than it typically is "not smoothe" as usual.There were no further complications or issues as the team swapped out the kit for a new one to avoid any potential compromise in the procedure.There was no additional time added to the case, no harm to the patient.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, g4, g7, h2, h6, h10.The device was not returned to maquet cardiac surgery for investigation; however photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact harvesting device.The c-ring was observed to be intact with no visual defects observed.The arms of the c-ring were observed to be intact with no visual defects observed and in a normal position when c-ring extended.Based on the returned condition of the device as well as the photographic evaluation, the reported failure "mechanical problem" was not confirmed as no mechanical evaluation was able to be conducted or observed in the photographs.The lot # 3000325468 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: VASOVIEW HEMOPRO 2
• 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: 17780421
• MDR Text Key: 323826577
• Report Number: 2242352-2023-00795
• Device Sequence Number: 1
• Product Code: GEI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000325468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1