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

Model Number VH-4001

Device Problems Crack (1135); Electrical /Electronic Property Problem (1198); Material Frayed (1262)

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

Event Date 01/26/2023

Event Type  malfunction  

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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 (w/vasoshield) black sheath/protector close to jaws cracked and frayed and then stopped working.There were no components of the crack/frayed device that detached into the harvesting tunnel / inside the patient.There were no procedural delay.They had to open another device to finish the case.There were no patient affects.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 3000284341 history record review was completed.There was one (01) ncmrs , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is a relation between the batch manufacturing process and the reported failure electrical/ electronic property problem.The lot # 3000284341 history record review was completed.There was no ncmrs , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is a no relation between the batch manufacturing process and the reported failures "material frayed" and "crack".H3 other text : device discarded.

• Brand Name: HEMOPRO 2 W/VASOSHIELD
• 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: 16416945
• MDR Text Key: 310342519
• Report Number: 2242352-2023-00136
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: 00607567700451
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 3000284341
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1