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

Model Number VASOVIEW HEMOPRO 2

Device Problems Peeled/Delaminated (1454); Fitting Problem (2183)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure when using vasoview hemopro 2 device to harvest the saphenous vein.After the dissection process was completed, the harvester began to use the hemopro 2 to ligate branches.During this time, it was noticed that the bisector was not sliding easily through the hemopro 2 cannula.The black coating only peeled back.It was therefore removed and inspected.It was immediately noticed that the black plastic coating near the jaws of the device had torn and peeled back.No pieces of the device were lost.No piece detached into the harvesting tunnel.However, it was felt that the product was no longer safe to use and it was therefore removed from the surgical field.There was a very slight procedural delay.Just the time it took to open up a new hemopro 2 kit and hand off the defective kit.Less than 3 minutes.The case was finished with no other complications.No injuries occurred due to the defect.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 12/15/202.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood were observed on the c-ring, jaws, and shaft of the harvesting device.The visible portion of the clear silicone insulation of the jaws was observed to be intact with no visual defects.The black shaft covering was observed to be peeled, exposing the metal shaft.Blood was visible on the metal shaft.An investigation was conducted on 12/27/2022.Signs of clinical use and evidence of blood were observed on the cannula, c-ring, and jaws of the harvesting device.Charred material was also observed on the jaws.The clear silicone insulation of the jaws and the heater wire were observed to be intact with no visual defects.A microscopic evaluation was conducted.The black shaft covering was observed to be peeled, exposing the metal shaft.Blood was visible on the metal shaft.A mechanical evaluation was conducted.A reference endoscope was inserted into the cannula until it audibly and visibly snapped into place with no physical or visual difficulties.The harvesting device was inserted through the port into the cannula.Heavy resistance was noted when inserting the harvesting device, specifically at the portion of the shaft where the shaft peeled.Based on the photographic inspection, the returned condition of the device, and the results of the investigation, the reported failures "peeled" and "fitting problem" were confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial conforms to all applicable product specifications.The lot # 3000275674 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: 16033394
• MDR Text Key: 308390617
• Report Number: 2242352-2022-01037
• Device Sequence Number: 1
• Product Code: GEI
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: 3000275674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1