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

Model Number VASOVIEW HEMOPRO 2

Device Problem Particulates (1451)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  Injury  

Event Description

Related to (b)(4).Summary: the hospital reported that during an endoscopic vein harvesting procedure, white plastic appearance left after transecting with vasoview hemopro 2 jaws.

Manufacturer Narrative

Trackwise id (b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, white plastic appearance left after transecting with vasoview hemopro 2 jaws.Procedure was delayed for a short duration due to needing to retrieve the plastic.No additional incisions required.Procedure was completed with same device.No harm to patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Trackwise # (b)(4).The device was not returned to maquet cardiac surgery for investigation, however a photograph was provided by the account.A photographic inspection was conducted on 02/16/2023.Signs of clinical use and a procedure was observed.White material was observed in the photograph closest to the harvesting device.The c-ring was observed to be intact with no visual defects observed.Based on the photographic evaluation, the reported failure "particulates" was confirmed, however due to the non-return of the device, we are unable to test the device.A lot history record review was completed for lots 3000263850, 3000262457, and 25163320 the last 3 lots shipped to the account prior to the event/aware date.For the lot # 3000263850: 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.For lot # 3000262457: 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.For lot # 25163320: there were two (02) 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: 14519793
• MDR Text Key: 292789674
• Report Number: 2242352-2022-00454
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention