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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV VASOVIEW 7 XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CV VASOVIEW 7 XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number C-VH-3200-J
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2016
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
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb, failed to inflate.The hospital did not report any patient effects.The product is returning.Connected the btt port and co2 injection line sent the gas did not expansion.Therefore operation time was prolonged 30 minutes.
 
Manufacturer Narrative
The device was returned to the factory for evaluation.A visual inspection was conducted.The device showed signs of clinical usage and evidence of blood.No nonconformance was observed to the balloon or inflation port.An inflation test was conducted.The balloon was inflated and submerged in plain water to observe the presence of bubbles.The device passed the inflation test, it remained inflated and no bubbles were observed under submersion.Based on the condition of the device as returned and the results of the investigation the reported complaint was not confirmed.(b)(4).
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb, failed to inflate.The hospital did not report any patient effects.The product is returning.Connected the btt port and co2 injection line sent the gas did not expansion.Therefore operation time was prolonged 30 minutes.
 
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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 Key5566040
MDR Text Key42946465
Report Number2242352-2016-00356
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K041981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/18/2016
Device Catalogue NumberC-VH-3200-J
Device Lot Number25120926
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2016
Is the Reporter a Health Professional? Yes
Device Age YR
Date Manufacturer Received06/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2015
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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