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

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.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: STEALTH 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 Key: 8684206
• MDR Text Key: 147501557
• Report Number: 3004742232-2019-00153
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005138
• UDI-Public: (01)10852528005138(10)(17)100706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR