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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERWIRE ADVANCED; CATHETER, PERIPHERAL, ATHERECTOMY
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CARDIOVASCULAR SYSTEMS INCORPORATED VIPERWIRE ADVANCED; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number VPR-GW-FT14
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/08/2016
Event Type  malfunction  
Event Description
After multiple passes with the cardiovascular systems, inc.(csi), we were attempting to take out the csi device.The physician realized the wire had broken off.X-rayed to see where wire was and was able to remove pieces of wire from sheath.The sheath was then removed.We removed as much as we could of the wire.The physician x-rayed and a piece was seen in small side branch in right foot.No blood flow was obstructed so the dr.Opted to leave in place because snaring would be too risky.The wire and box was saved.
 
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Brand Name
VIPERWIRE ADVANCED
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS INCORPORATED
14740 kirby dr.
houston TX 77047
MDR Report Key6431616
MDR Text Key70812444
Report Number6431616
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Unknown
Device Catalogue NumberVPR-GW-FT14
Device Lot Number165607
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/08/2017
Event Location Hospital
Date Report to Manufacturer03/08/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Age83 YR
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