MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2021

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 using vasoview hemopro vh-3500, the grey silicone tip of the hemopro jaws became separated.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise id# (b)(4).The lot # 25155304 history record review was completed.There is an ncmr # 17217, which was a sterilization issue and a discrepancy in the maximum dose specification and not a product issue.There were no 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.The device was returned to the factory on 03mar2021 and investigated on 04mar2021.There were signs of clinical use on the jaws.Charred tissue was observed on the heater wire.A visual inspection device was conducted.The silicone insulation on the cold jaw was approximately all the way torn, but not detached.The heater wire was observed to be slightly twisted and completely flexed away from the center of the hot jaw, remaining attached at the base, and the tip of the hot jaw.Based on the condition of the device as found, the reported failure mode was confirmed for ¿peeled; jaw" and analyzed failure mode was confirmed for "material twisted/bent; wire".

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500, the grey silicone tip of the hemopro jaws became separated.Nothing fell into the patient.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11378963
• MDR Text Key: 233555464
• Report Number: 2242352-2021-00185
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2021
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 25155304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1