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

Model Number	SIP-3000
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: STEALTH SALINE INFUSION PUMP
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul MN 55112
• MDR Report Key: 8684206
• Report Number: 3004742232-2019-00153
• Device Sequence Number: 19398097
• Product Code: MCW
• UDI-Device Identifier: 10852528005138
• UDI-Public: (01)10852528005138(10)(17)100706
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIP-3000
• Device Catalogue Number: 70057-03
• Device Lot Number: 100706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR