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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE) Back to Search Results
Model Number VPR-GW-17
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/29/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Since the patient was transferred to another facility, information about further treatment received by the patient is unknown. The results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. The device history record for this oad lot number has been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The device met material, assembly, and quality control requirements. Csi id: (b)(4).
 
Event Description
The viperwire guide wire was positioned with the tip in the tibioperoneal trunk during treatment of a lesion in the superior femoral artery; the placement was distal to allow for use of a non-csi filter. A small perforation in the peroneal artery was seen on imaging following successful treatment of the lesion and subsequent filter retrieval. The physician determined that no treatment was necessary for the perforation due to its small size. The procedure was completed, and compression was not applied to the area. Later in the same day, the patient was transferred to another facility due to compartment syndrome in the lower extremity. As of 7 april 2021, the patient was well.
 
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Brand NameDIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
Type of DevicePERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key11699865
MDR Text Key246483527
Report Number3004742232-2021-00141
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberVPR-GW-17
Device Catalogue Number72023-02
Device Lot Number346754-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2021 Patient Sequence Number: 1
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