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

Model Number VASOVIEW HEMOPRO 2

Device Problem Defective Device (2588)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

Related 694972 the hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 did not have the hole cutout for the knot pusher to be used to close intracaporal.The hole is supposed to be in the harvesting cannula.Harvester uses the hole to push the knot of the endoclose in radials.This device was being used for a radial and user uses the endoclose to tie off.No injury was caused to the patient and a second device was used that also did not have the hole so a third device was used to complete the case.

Manufacturer Narrative

Trackwise id (b)(6).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.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 10/20/2022.An investigation was conducted on 11/02/2022.A visual inspection was conducted.The complete device assembly was returned in its packaging.No signs of clinical use or evidence of blood was observed on the device.There were no visual defects observed on the harvesting device, accessories, or cannula.A microscopic inspection was conducted.The endoloop hole in the end of the c-ring (metal rod side) was visible.A needle was utilized to test the fabrication and depth of the hole.It was able to be partially passed through, but the hole was observed to be occluded by the plastic material of the c-ring and could not pass entirely through.Based on the returned condition of the device and the results of the evaluation, the reported failure "defective device" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 3000249229 history record review was completed.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.

• 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: 15591762
• MDR Text Key: 305547482
• Report Number: 2242352-2022-00856
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 3000249229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1