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

Model Number VASOVIEW HEMOPRO 2

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, they noticed that a piece of metal was protruding out above the hemo pro jaws.They opened a new device to complete the procedure.No injury.

Manufacturer Narrative

Internal tw# (b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, they noticed that a piece of metal was protruding out above the hemo pro jaws.No difficulty inserting or retracting device.Device inserted correctly.No bend in shaft.They opened a new device to complete the procedure.No injury.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, they noticed that a piece of metal was protruding out above the hemo pro jaws.No difficulty inserting or retracting device.Device inserted correctly.No bend in shaft.They opened a new device to complete the procedure.No injury.

Manufacturer Narrative

Corrected section: b5- summary.Internal complaint number: (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.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaint 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 (b)(6) 2019 to (b)(6) 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.Investigation findings (13); investigation conclusions(22): the device was not returned to maquet cardiac surgery for investigation, however a photograph was provided by the account.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed in the plastic tray.The jaws were observed to be intact, no visual defects were observed.A metal piece was observed in the upper portion of the shaft.No other visual defects were observed.Based on the photographic inspection, the reported failure " material protrusion/extrusion" was confirmed, however we are unable to determine when the reported failure occurred due to the non-return of the device.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 12455230
• MDR Text Key: 271696187
• Report Number: 2242352-2021-00725
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25159146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 62