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

Model Number	DBP-EX-125SOL145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).
Event or Problem Description
The diamondback exchangeable orbital atherectomy device (oad) was used to treat lesions in the tibioperoneal trunk and the superficial femoral artery via femoral access.The aorto-iliac bifurcation was very acute in angulation, and the common iliac arteries were heavily calcified and tortuous.The oad was pulled back through the guide catheter, and the driveshaft fractured.The fragment was snared via additional access in the right common femoral artery.The procedure was then completed using the new access point.
Additional Manufacturer Narrative
Device analysis conclusion: the oad and guide wire were received at csi for analysis.The guide wire was engaged in the oad.Visual examination confirmed the reported driveshaft fracture at the proximal edge of the crown.Scanning electron microscopy analysis revealed the driveshaft fractured due to fatigue.The damage is consistent with localized, elevated stress levels applied to the driveshaft while spinning.The report that the driveshaft fractured was confirmed though analysis, but the exact root cause of the fracture could not be determined.The report that the oad became stuck in an accessory could not be confirmed through analysis; there were no abnormalities identified that would have contributed to the device becoming stuck in an accessory.The device functioned as intended during testing.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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 11692185
• Report Number: 3004742232-2021-00092
• Device Sequence Number: 3018238
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)220930(10)347394
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 09/30/2022
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: 7-10030-02
• Device Lot Number: 347394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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 Weight: 53