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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO BTT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CV VASO VIEW HEMOPRO BTT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number C-VH-3000
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2016
Event Type  malfunction  
Manufacturer Narrative
On 02/22/2016 02:16 pm (gmt-5:00) added by (b)(6): the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.Cs-cpl-2016-00069; (b)(6).
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro would not inflate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.
 
Manufacturer Narrative
(b)(4).Device evaluation: the btt was returned to the factory for evaluation.No signs of blood with some signs of clinical use were observed.A visual inspection was performed.There was no evidence of tears, punctures or pinholes.No defects were observed on the valve stem and no cracks were observed on the luer fitting.No blockages or adhesive migration were observed.The device function was evaluated.The btt was inflated with 50cc of air to test for leaks.A bubble emission leak test was performed.The balloon remained inflated.No leaks were observed.We were not able to reproduce the reported failure.It is not possible to confirm the reported complaint.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro would not inflate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.
 
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Brand Name
VASO VIEW HEMOPRO BTT
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 Key5451725
MDR Text Key39162577
Report Number2242352-2016-00158
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2016
Device Catalogue NumberC-VH-3000
Device Lot Number25121141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2016
Is the Reporter a Health Professional? No
Device Age YR
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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