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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. ORBITAL ATHORECTOMY GUIDEWIRE VIPER WIRES

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CARDIOVASCULAR SYSTEMS INC. ORBITAL ATHORECTOMY GUIDEWIRE VIPER WIRES Back to Search Results
Model Number VPR-GW-FT14
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problems Pain (1994); Thrombosis (2100)
Event Date 08/25/2017
Event Type  Injury  
Event Description
On (b)(6) 2017: patient underwent arteriogram, orbital atherectomy and balloon angioplasty on right lower extremity and discharged home. On (b)(6) 2017: patient presented to ed with right calf path and discoloration of right foot - patient admitted to hospital. On (b)(6) 2017: patient underwent arteriogram, fluoroscopic guided intra-arterial foreign body retrieval and catheter directed arterial thrombolytic lysis. Foreign body identified as 70cm wire fragment from guidewire. On(b)(6) : patient underwent repeat arteriogram and arterial mechanical thrombectomy. On (b)(6) patient underwent right open 4 compartment release of right lower extremity. On (b)(6) patient underwent us guided vascular access, arteriogram and right groin exploration with thrombectomy followed by bovine batch angioplasty, intrapopliteal artery exploration with below knee thrombectomy, posterior tibial artery exploration at ankle with thrombectomy. On(b)(6) patient remains hospitalized with severe pain to right leg, wound vac in place.
 
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Brand NameORBITAL ATHORECTOMY GUIDEWIRE
Type of DeviceVIPER WIRES
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS INC.
st. paul MN 55112
MDR Report Key6914001
MDR Text Key88269897
Report NumberMW5072597
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberVPR-GW-FT14
Device Catalogue NumberVPR-GW-FT14
Device Lot Number196571
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/04/2017 Patient Sequence Number: 1
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