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

Model Number VASOVIEW HEMOPRO 2 (W/VASOSHIELD)

Device Problem No Flow (2991)

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

Event Date 03/31/2022

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

Additional complaint record has been created due to unrelated failure mode (s) tw id (b)(4).The hospital reported that during an endoscopic vein harvesting procedure vasoview hemopro 2 (w/vasoshield ) to harvest the saphenous vein.When co2 attached to the device, no co2 would flow through the hemopro 2 and into the tunnel in the leg.The connection was inspected and reconnected several times and the same defect still occurred.The remainder of the case was finished with the new kit and no further issues occurred.

Manufacturer Narrative

Trackwise#: (b)(4).The lot # 25161423 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.H3 other text : device discarded.

Event Description

N/a.

• Brand Name: VASOVIEW HEMOPRO 2 (W/VASOSHIELD)
• 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: 14197326
• MDR Text Key: 290155001
• Report Number: 2242352-2022-00359
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: 00607567700451
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: VASOVIEW HEMOPRO 2 (W/VASOSHIELD)
• Device Catalogue Number: C-VH-4001
• Device Lot Number: 25161423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.