MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; CLAMP, VASCULAR

Model Number VASOVIEW HEMOPRO 2

Device Problem Inflation Problem (1310)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 btt port is set and the balloon is inflated, it will deflate and an event that cannot be fixed will occur.The balloon did not inflate.They opened the new device, it can be used without problems, and the operation is completed successfully.

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.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period dec 2019 through nov 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 & 4105/13/22) enter investigation the device was returned to the factory for evaluation on 04/13/2022.An investigation was conducted on 04/25/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The btt was observed to be intact.A mechanical investigation 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.There was no backflow observed in the co2 line.A leak was observed on the side of the silicone balloon.The btt was unable to be inflated.No visual defects were observed on the silicone btt.Based on the condition of the device, the reported failure "inflation issue" was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 btt port is set and the balloon is inflated, it will deflate and an event that cannot be fixed will occur.The balloon did not inflate.They opened the new device, it can be used without problems, and the operation is completed successfully.There is no impact on the patient.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: CLAMP, VASCULAR
• 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: 12956578
• MDR Text Key: 285989471
• Report Number: 2242352-2021-01021
• Device Sequence Number: 1
• Product Code: DXC
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25159538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1