MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	DBP-200SOLID145
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a device malfunction occurred.The target lesion was 95% stenosed and located in the superficial femoral artery (sfa).The lesion was treated with six passed of the oad on low, medium and high speeds.Following the final pass on high speed, the device would not turn off when the power button was pressed and continued to spin.The power button was pressed multiple times, however the device did not turn off.The brake mechanism was lifted to deactivate the device and the procedure was completed with balloon angioplasty.No patient complications were reported and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
The reported oad was received for analysis.When functionally tested, the device turned on and off numerous times and functioned as intended with no anomalies observed.The device underwent an electrical engineering diagnostic evaluation and no issues were found.At the conclusion of the device analysis investigation, the reported event was unable to be replicated and the cause of the event could not be 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.(b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 7683230
• Report Number: 3004742232-2018-00206
• Device Sequence Number: 1398704
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)190228(10)182573
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• 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,Followup
• Report Date (Section B): 09/12/2018

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 Expiration Date: 02/28/2019
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 182573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 93