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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM STEALTH SALINE INFUSION PUMP

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM STEALTH SALINE INFUSION PUMP Back to Search Results
Model Number SIP-3000
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
The reported saline pump was returned for analysis with the diamondback peripheral orbital atherectomy device (oad) and viperwire guide wire utilized during the procedure. A visual analysis did not reveal any damage to any of the devices. The pump was activated and tested at both low and high speeds. The pump operated as intended during all functions and no anomalies were noted. The oad was examined and there was no damage to the saline line, nose cone assembly, or other components which may have contributed to the reported event. The oad was connected to the saline pump and saline line, and fluid was infused through the handle assembly, saline sheath and driveshaft with no issue. At the conclusion of the device analysis investigation, the reported event was unable to be confirmed and the root cause is unknown. All returned components functioned as intended. The device history records for these devices have been reviewed. No issues or discrepancies were noted during this review that would have contributed to the reported event. The devices met material, assembly, and quality control requirements prior to distribution. (b)(4).
 
Event Description
During treatment of a lesion with a diamondback peripheral orbital atherectomy device (oad), blood was observed flowing back into the device. The blood was unable to be flushed from the device using the saline pump. A second pump was used and functioned without issue, and the procedure was completed with the original oad. There were no patient complications reported.
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DeviceSTEALTH SALINE INFUSION PUMP
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
st. paul MN 55112
Manufacturer Contact
laramie otto
1225 old highway 8 nw
st. paul, MN 55112
6512691600
MDR Report Key8684206
MDR Text Key147501557
Report Number3004742232-2019-00153
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130005
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 06/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSIP-3000
Device Catalogue Number70057-03
Device Lot Number100706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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