MAUDE Adverse Event Report: MAQUET CV VASOVIEW 7 XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3200

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb dissector piece was not screwed in properly prior to inserting into the tunnel.The leg started to bleed due to excessive heparin administration.When the scope was pulled out the dissector piece was not on the scope and had dislodged in the evh tunnel.An additional incision in the mid- thigh was done, the dissector piece was located and retrieved in one piece.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lots 25127404, 25127914 and 25128288 the last 3 lots shipped to the account prior to the event date.There was no nonconformance which could be considered related to the reported event recorded in the lot history.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb dissector piece was not screwed in properly prior to inserting into the tunnel.The leg started to bleed due to excessive heparin administration.When the scope was pulled out the dissector piece was not on the scope and had dislodged in the evh tunnel.An additional incision in the mid- thigh was done, the dissector piece was located and retrieved in one piece.The hospital did not report any patient effects.

• Brand Name: VASOVIEW 7 XB
• 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: 6182572
• MDR Text Key: 62671091
• Report Number: 2242352-2016-01294
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041981
• 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: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-3200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/30/2017
• 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 Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 110