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

Model Number VH-4000

Device Problems Inflation Problem (1310); Improper Flow or Infusion (2954)

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

Event Date 02/18/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 pressure increased to 50 mm hg when a co2 insufflation tube was connected to the co2 infusion line of the vasoview cannula and sent.Co2 set flow rate was 3l/min pressure was 10 mm hg.No leakage was observed.They tried several times, but the pressure rose to 50 mm hg, so we decided to change the device.As a result, the pressure was reduced to 10 mm hg.There was no delay in the procedure.The operation was completed without any problems, and the patient had no problems.

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

Unk.

Manufacturer Narrative

Trackwise #(b)(4).Corrected section: medical device ¿ problem code (1) - corrected to 2954.The lot # 25160419 history record review was completed.There were 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 not returned.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: h4- if other provide code -explain- device returned, h6 -investigation findings (1) removed code "3221"- device returned, h6 -type of investigation removed code " 4114- device returned, d10- device available for eval- device returned.The device was returned to the factory for evaluation on 03/23/2023, however the device was brought to the lab for evaluation on 05/17/2023.Signs of clinical use and no evidence of blood was observed on the intact cannula.The insufflation tube and the water tube were observed to be intact.The device was evaluated for the presence or absence of air flow through the distal insufflation tube using a cannula with the help of calibrated uson (id 14332 due: 01/31/2024).A reference endoscope was inserted into a returned vv7 cannula and an air supply was connected to the distal insufflation tubing luer fitting.Air was passed through the insufflation port and was observed to flow freely through the distal port.To verify this, a pouch was sealed over the distal tip of the cannula.Air was passed through the cannula and the pouch was inflated.The air supply was stopped and the pouch stayed inflated.When gentle pressure was applied to the inflated pouch, the pouch deflated slightly, the air was turned back on and the pouch re-inflated.The device passed the air flow test, the co2 insufflation path on the complaint unit was open and unobstructed.The values displayed were within specified acceptable range which is 2193 sccm.Based upon the returned condition of the device and the results of the investigation, the reported failure "improper flow or infusion" was not confirmed.

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: 16544470
• MDR Text Key: 311765626
• Report Number: 2242352-2023-00199
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 25160419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose