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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 CLAMP, VASCULAR Back to Search Results
Model Number VASOVIEW HEMOPRO 2
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise #(b)(4). The lot # 25148095 history record review was completed. There were no ncmrs, rework, or deviations documented for the reported lot number. Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure. 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 using vasoview hemopro 2, they confirmed the tip of jaw peeled off. Nothing fall into the patient. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameVASOVIEW HEMOPRO 2
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
dorota wolpiuk
45 barbour pond drive
wayne, NJ 07470
MDR Report Key11142895
MDR Text Key226019590
Report Number2242352-2021-00044
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K101274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2021
Device Model NumberVASOVIEW HEMOPRO 2
Device Catalogue NumberC-VH-4000
Device Lot Number25148095
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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