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

Model Number	7-10018/DBP-200SOLID145
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code: appropriate term/code not available.Suggested code: difficulty advancing/withdrawing the device.Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.
Event or Problem Description
During a case with a peripheral diamondback orbital atherectomy device (oad), a 6fr sheath was used in the common femoral artery in a female patient with a target lesion in the left illiac artery.The oad shaft could not be advanced into the lesion from the common femoral artery, and a radial approach was used to continue the procedure.The oad stopped spinning during the procedure.Difficulty was encountered when removing the oad from the patient.A possible type a vessel dissection was noted in the external illiac vessel.The lesion and possible dissection were stented, and the procedure was completed with a 30-40 minute delay due to the reported issues.The patient was well following the procedure.
Additional Manufacturer Narrative
When tested the oad functioned as intended with no anomalies noted.Elongation damage was observed on the driveshaft during visual inspection.While it is possible the damage may have been caused by handling and manipulation during the procedure, the cause of the damage could not be conclusively determined.At the conclusion of the failure analysis investigation the event could not conclusively be confirmed through analysis.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 7821921
• Report Number: 3004742232-2018-00268
• Device Sequence Number: 11091149
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)200131(10)214046
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 7-10018/DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 214046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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