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

Catalog Number C-VH-4000

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

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.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).

Event Description

During branch ligation of the saphenous vein, (b)(6), who was harvesting the vein, noticed that there was a wire protruding out between the cutting jaws.The jaws would not capture and cauterize tissue properly.

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device was returned to the factory for evaluation.A visual inspection was performed.Signs of clinical usage and evidence of blood were observed.The heater wire was flexed away from the hot jaw and was detached at the tip.Charred blood and tissue build up was observed.The wire remained in place at the base of the jaws.Based on the returned condition of the device the reported complaint was confirmed for the reported failure mode ¿heater wire -bent/detached¿.Specific actions for the failure mode are being documented and maintained under maquet's corrective and preventive action (capa) system.

Event Description

During branch ligation of the saphenous vein, (b)(6), who was harvesting the vein, noticed that there was a wire protruding out between the cutting jaws.The jaws would not capture and cauterize tissue properly.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5631355
• MDR Text Key: 44890862
• Report Number: 2242352-2016-00423
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2017
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25123445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR