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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Code Available (3191)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received for analysis.A visual examination identified adhered biological material on the driveshaft and crown of the device, which prevented a guide wire from passing through.It is possible that the tissue accumulation during operation of the device prevented the device from spinning freely, however this could not be confirmed.When tested, the oad would not spin unless constant pressure to the brake lever was applied.Upon further examination, the oad brake switch was found to be misaligned with the brake switch plate, and stress fractures were noted on the brake securing tabs.When the brake switch was disconnected from the brake assembly and manually depressed, the device functioned as intended.The cause of the brake damage is unknown.As it was reported that the oad functioned as intended during the first passes performed during the reported event and only stopped spinning when tissue wrap was noted, the adhered tissue is considered to be the primary finding of this device analysis.At the conclusion of the device analysis investigation, the reported events of dissection, vessel spasm and limited flow were unable to be confirmed.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).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection, no flow event, and vessel spasms occurred.The target lesion was 95% stenosed and located in the tibular-fibular trunk.The lesion was treated with three passes of the oad on low and medium speeds.During the third pass, the oad appeared to stop spinning.The oad and guide wire were removed and tissue wrap was noted on the crown of the oad.There was no flow to the vessel, and the lesion was re-wired to perform balloon angioplasty.Slow flow still remained and medications were administered to treat a possible thrombus.A dissection was identified and vessel spasms occurred.Balloon angioplasty was performed again to restore flow and the patient was in stable condition following the procedure.

• 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: 7568699
• Report Number: 3004742232-2018-00152
• Device Sequence Number: 18864756
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)200229(10)218702
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/29/2020
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 218702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 87