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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 PERIPHERAL ATHERECTOMY DEVICE

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CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number SIP-3000
Device Problem Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
The reported saline infusion pump was received at csi for analysis. The pump was turned on, and when the primer button was depressed, the pump defaulted to standby mode. Diagnostic evaluation of the saline pump data revealed a pump spin direction fault issue. The pump motor connector and cable set revealed a damaged connector receptor for the motor spin direction cable. The root cause of the damaged receptor was unable to be determined. The connector receptor was moved to ensure a proper connection, and the pump was retested. During retesting, the pump functioned as intended. At the conclusion of device analysis, the reported event of the saline pump going into standby mode was confirmed. The device history record for this saline pump 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. (b)(4).
 
Event Description
The neptune saline infusion pump unexpectedly went into standby mode when it was turned on. All pump connections had been checked. The procedure was completed with plain old balloon angioplasty (poba). It was noted that the procedure was delayed greater than 30 minutes to troubleshoot the event. The patient experienced no complications. The opinion of the physician was that the angioplasty would have yielded much better results if orbital atherectomy had been used.
 
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Brand NameDIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old highway 8 nw
saint paul MN 55112
Manufacturer Contact
sarah hicks
1225 old highway 8 nw
saint paul, MN 55112
MDR Report Key9186335
MDR Text Key194476071
Report Number3004742232-2019-00266
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 10/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSIP-3000
Device Catalogue Number7-10037-01
Device Lot Number287074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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