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

Model Number VH-3500

Device Problem Fitting Problem (2183)

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

Event Date 03/31/2024

Event Type  malfunction  

Event Description

The hospital reported that vaso view hempro (us) vh-3000 failed.; when the device was inserted into the harvesting cannula, it was initially a little tight.The device was removed and lubricated with mineral oil.It slid much easier.The procedure was completed with the same device.It was also noted that the picture through the scope was poor due to light source issues and monitor coloring was off; it was not thought to be an issue with the evh kit.There was no patient harm.

Manufacturer Narrative

Tw (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).The device was returned to the factory for evaluation on 05/08/2024.An investigation was conducted on 05/13/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The harvesting device was returned inside the cannula.There were no visual defects observed on either the cannula or the harvesting device.The harvesting device was removed from the cannula with no physical or visual difficulties observed.A reference endoscope was inserted into the scope port until it snapped into place with no physical or visual difficulties observed.The harvesting device was then inserted into the cannula with no physical or visual difficulties observed.Based on the returned condition of the device as well the evaluation results, the reported failure "fitting problem-tool" was not confirmed.The lot # 3000376542 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

The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 failed.When the device was inserted into the harvesting cannula, it was initially a little tight.The device was removed and lubricated with mineral oil.It slid much easier.The procedure was completed with the same device.It was also noted that the picture through the scope was poor due to light source issues and monitor coloring was off; it was not thought to be an issue with the evh kit.There was no procedural delay.There was no patient harm.

• Brand Name: VASOVIEW HEMOPRO
• 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: 19183749
• MDR Text Key: 341143787
• Report Number: 2242352-2024-00424
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000376542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1