MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3000

Device Problem Inflation Problem (1310)

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

Event Date 08/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Corrected statement.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(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, vasoview hemopro btt port balloon did not properly inflate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lots 25115656, 25116317 and 25117403 the last 3 lots shipped to the account prior to the event date.There was no nonconformance recorded in the lot history.The device was returned to the factory for evaluation.It showed signs of clinical usage and evidence of blood.A visual inspection identified a small puncture in the center of the silicone balloon, roughly 2mm across.The puncture exhibited smooth sides with no removal of material and no tearing and was not located near the suture seam.The balloon will not inflate.Bubbles were seen rapidly releasing from the puncture during a bubble emission test in plain water.Based on the condition of the device as found the reported complaint for "btt malfunctioned/stopped working" was confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro btt port balloon did not properly inflate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASO VIEW HEMOPRO
• 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: 5080768
• MDR Text Key: 26255914
• Report Number: 2242352-2015-01080
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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