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

Model Number VH-4000

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

Tw 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

Medwatch report number: 5201770000-2024-8040.Related to tw (b)(4).The hospital reported that during endoscopic vein harvesting procedure, vasoview hemopro 2 read "occlusion" when it was plugged into co2 insufflation.Harvester tried new insufflation tubing with no success.With no insufflation, surgical assistant could not continue with laparoscopic approach after multiple attempts with two different harvesters.New tower with insufflation was attempted with no success either.

Manufacturer Narrative

Trackwise#: (b)(4).Corrected sections: b3--date of event corrected from "02/09/2024" to "02/08/2024.".

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/15/2024.An investigation was conducted on 02/29/2024.A visual inspection was conducted.The harvesting device, cannula and 2 btts were returned for evaluation.There were no visual defects observed on either the harvesting device or the cannula.Signs of clinical use and evidence of blood was observed on the two btts that were returned.An email was sent to intake in regards to the 2nd btt returned.The rep stated that the 2nd btt was not related to the complaint and it was used since the 1st one failed.Attached email.Since we are unable to determine which btt failed, both btts were evaluated.No visual defects were observed on the intact btts.A mechanical evaluation was conducted.The btt was able to be inflated.No visual defects were observed on the silicone btt.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.The cannula was observed to be intact, no visual defects were observed.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 (b)(4) due: (b)(6) 2024).A reference endoscope was inserted into a reference 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 test was then repeated for the reported cannula.The reference endoscope was inserted into the complaint device and evaluated for air flow.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 2195 sccm.Based on the returned condition of the devices as well as the evaluation results, the reported failure "improper flow or infusion" was not confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system the lot # 3000336966 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.

• 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: 18845642
• MDR Text Key: 337122299
• Report Number: 2242352-2024-00185
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 3000336966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INSUFFLATION TUBING, TOWER
• Patient Age: 74 YR
• Patient Sex: Male