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

Model Number VASOVIEW HEMOPRO 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Abdominal Distention (2601)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

Trackwise 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 Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, they were harvesting the greater saphenous vein and had a really good tunnel but noticed bleeding when cutting branches more than normal.The patients¿ abdomen had also become distended and the patient was hypotensive.They ended up needing to make more than one incision in the leg because of the bleeding to safely get the vein out.They realized afterward that the co2 was not connected to the regulator on the tower but to a continuous wall unit at 6l/minute.The patient tolerated the remainder of the surgery ok with no postop issues.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, they were harvesting the greater saphenous vein and had a really good tunnel but noticed bleeding when cutting branches more than normal.The patient¿s abdomen had also become distended and the patient was hypotensive.They ended up needing to make more than one incision in the leg because of the bleeding to safely get the vein out.They realized afterward that the co2 was not connected to the regulator on the tower but to a continuous wall unit at 6l/minute.Procedure completed with the open technique.The patient tolerated the remainder of the surgery ok with no postop issues.

Manufacturer Narrative

Trackwise id # (b)(4).Corrected sec- h3 changed to device discarded.Device discarded: (4115) despite request and/ or customer indicated that the device was discarded; however, the actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing.H3 other text : device discarded.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).A lot history record review was completed for lots 25161873, 25162188, and 25162201 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.It is not possible to confirm the reported complaint.

• 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: 13949325
• MDR Text Key: 288183148
• Report Number: 2242352-2022-00275
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male