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

Model Number VH-4000

Device Problem Infusion or Flow Problem (2964)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Tw 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

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 sufficient flow was not achieved during the application.In particular, it is about the so-called co2 insufflation port with one-way valve, which is used, among other things, in the short port blunt tip trocar (btt).As it turns out, the (blue) valve is not pressed or not pressed sufficiently, so that only a reduced flow is available.This in turn is due to the fact that this connection only covers a small part of the luer connections to be connected.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 sufficient flow was not achieved during the application.In particular, it is about the so-called co2 insufflation port with one-way valve, which is used, among other things, in the short port blunt tip trocar (btt).As it turns out, the (blue) valve is not pressed or not pressed sufficiently, so that only a reduced flow is available.This in turn is due to the fact that this connection only covers a small part of the luer connections to be connected.Completed with same device.Delay due to limited insufflation.No patient harm reported.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: e3- occupation- corrected to" nurse".A lot history record review was completed for lots 3000344376, 3000341750, and 3000339700, the last 3 lots shipped to the account prior to the aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.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 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: 18184526
• MDR Text Key: 328976971
• Report Number: 2242352-2023-00978
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STRYKER TOWER