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

Model Number VASOVIEWHEMPRO (OUS) VH-3000

Device Problems Electrical /Electronic Property Problem (1198); Inflation Problem (1310)

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

Event Date 09/18/2023

Event Type  malfunction  

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

Hospital reported vasoview hemopro (ous) vh-3000 balloon of btt cannot be inflated.Pre-cautery test performed per the ifu, but cannot pass the pre-cautry test and they cannot inflate the btt due to the balloon leakage.Problem solved when another new set of hemopro is opened.Generator is not functioning when cable and hemopro attached.There was no beeping sound from the generator, so they opened another unit to complete the procedure.Same cable and same generator was being used.No delay.No harm.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, d10, g4, g7, h2, h3, h6, h10 the device was returned to the factory for evaluation on (b)(6) 2023.An investigation was conducted on (b)(6) 2023.A visual inspection was conducted.Signs of clincial use and evidence of blood was observed.There were no visul defects observed on the returned accessories.There were no visual defects observed on the intact returned cannula.The c-ring was observed to be intact with no visual defects observed.There were no visual defects observed on the intact btt.A mechanical evaluation was conducted.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.No leaks were observed on the silicone balloon.The btt was able to be inflated.There were no visual defects observed on the intact gray silicone insulation on both the cold and hot jaws.The heater wire was observed to be intact with no visual defects observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu cv000006799) with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test.It produced visible steam during several activations over a period of 10 minutes and shut off when the toggle was released.The pre-cautery test was repeated 10 times while the cable connections were manipulated with no observed failure.An activation and transection capability test was performed over four (04) repetitions using "max life, test method" stm2048073 (bacon test).The device activated and transected the tissue five (5) times with no cautery failure observed.Based on the returned condition of the device as well as the evaluation results, the reported failures "inflation problem" and "electrical issue" were not confirmed.The lot # 3000293031 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.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

(b)(4).The lot # 3000293031 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.

• Brand Name: VASOVIEW HEMOPRO, OUS
• 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: 17940827
• MDR Text Key: 325748053
• Report Number: 2242352-2023-00848
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700413
• UDI-Public: 00607567700413
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: VASOVIEWHEMPRO (OUS) VH-3000
• Device Catalogue Number: VH-3000-W
• Device Lot Number: 3000293031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Prefer Not To Disclose