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

Model Number VH-4000

Device Problem Inflation Problem (1310)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

(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

The hospital reported that vasoview hemopro 2 had 20cc of air into the btt port with a 30cc syringe to expand the balloon.When the 30cc syringe was pulled out, the air also escaped and the balloon could not be expanded.The balloon inflated, but failed to remain inflated.The balloon did not burst.It was unclear where the air escaped.A new device was opened to complete the procedure using the btt port.There was no major delay and no impact on patient.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation on 02/26/2024.An investigation was conducted on 02/27/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.The harvesting device, cannula, and accessories were observed to be intact with no visual defects.There were no visual defects observed on the 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 with no issues.The btt was able to be inflated with 30cc of air, however when the syringe plunger was released, the air escaped and the balloon deflated.A leak test was conducted by placing the inflated balloon in water, however no leaks were observed on the silicone balloon.An engineer evaluation was conducted on 3/15/2024.A 30cc syringe was inserted into the leur lock valve (cv000000854) of the complaint device to inflate the balloon.The balloon inflated normally, but when the syringe was removed from the leur lock valve the balloon did not stay inflated.The btt subassembly ((b)(6)) was inspected under magnification.It was observed that the leur lock valve was damaged.Based on the returned condition of the device, investigation results, and engineer evaluation, the reported failure "inflation problem" was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000333517 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.

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: 18822209
• MDR Text Key: 337220055
• Report Number: 2242352-2024-00174
• Device Sequence Number: 1
• Product Code: GEI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 3000333517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.