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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism (1829); No Code Available (3191)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Failure analysis conclusion: the device was received at csi for investigation without the guide wire.Shipping damage was observed and removed to allow for functional testing.An in-house test wire was passed through the device without issue.There was no other damage observed with the oad.When tested, the device functioned as intended.At the conclusion of the failure analysis investigation the reported possible spasm and embolism were not confirmed.There was no damage or abnormalities observed with the oad or driveshaft that would have contributed to the reported complaint.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.The diamondback360® peripheral orbital atherectomy system instructions for use manual states that distal embolization and vessel spasm are adverse events that can occur during use of the device.(b)(4).
Event or Problem Description
Atherectomy was performed on low, medium, and high speeds with a diamondback peripheral orbital atherectomy device.The treatments were performed in the popliteal artery.A stent was placed with good angiographic result.Imaging showed possible spasm and embolization in the posterior tibial (pt) artery.Attempts to rewire the vessel with a non-csi wire caused a complication in the pt artery.This complication was not caused by csi product.The complication was not treated; the patient was monitored.The patient had an observable pulse in the pt artery on ultrasound and was discharged on (b)(6) 2019.

• 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: 9167518
• Report Number: 3004742232-2019-00263
• Device Sequence Number: 16811647
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)210630(10)276766
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/08/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 276766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/08/2019
• 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: Other