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

Model Number VH-3500

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Tw 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 the ligation phase of an endoscopic vessel harvesting procedure, vasoview hempro vh-3500 metal filament separated from hemopro jaw.The hemopro jaws were not actively held shut during insertion into the cannula.A 2nd evh kit was opened to complete the case.Only delay came from opening 2nd unit.Nothing was retained in the patient and no reported patient injury.Per photo provided by complainant, there is evidence of the metal heating wire separated from the jaw.

Event Description

N/a.

Manufacturer Narrative

Trackwise (b)(4) updated sections: b4, g3, g6, h2, h3, h6, h10 the device was returned to the factory for evaluation on 03/01/2024.A photograph was provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact silicone insulation on both the cold and hot jaws.The heater wire was observed to be flexed away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.No other visual defects were observed.An investigation was conducted on 03/05/2024.A visual inspection was conducted.Both the harvesting device as well as the cannula was returned for evaluation.There were no visual defects observed on the intact cannula or the intact c-ring.There were no visual defects observed on the silicone insulation on both the cold and hot jaws.The heater wire was observed to be flexed away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.No other visual defects were observed.Based on the photographic evaluation as well as the condition of the device as well as the evaluation results, the reported failure "material twisted/bent wire" was confirmed.The lot # 3000362933 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
• 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: 18866212
• MDR Text Key: 337223210
• Report Number: 2242352-2024-00216
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000362933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 89 KG