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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure analysis conclusion: the oad was returned to csi for analysis with the guide wire stuck in the driveshaft.Visual examination indicated that the cause of the stuck oad was that the spring tip of the viperwire had been spun over, which resulted in distal coil and support ribbon fractures.Fragments of the fractured spring tip coils and proximal solder bond were found inside the driveshaft filars and tip bushing section.Scanning electron microscopy analysis of the guide wire spring tip identified severe axial mechanical damage on the proximal solder bond lodged within the tip bushing.The extent of mechanical damage was beyond the damage typically seen after a driveshaft is spun over the spring tip.It is hypothesized that the driveshaft made contact with the spring tip multiple times until the fragmentation occurred.Therefore, the complaint of the device becoming stuck on the guidewire is a result of spinning the driveshaft into the guidewire spring tip.At the conclusion of the failure analysis investigation the stuck-on-wire event was 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.Prior to distribution the device met material, assembly, and quality control requirements.(b)(4).
Event or Problem Description
The original event indicated the diamondback peripheral orbital atherectomy device became stuck on the viperwire during the procedure.The oad and wire were removed together and the vessel was re-wired.The procedure was completed successfully.Device analysis revealed that device fractures had also occurred.

• 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: 8298346
• Report Number: 3004742232-2019-00044
• Device Sequence Number: 16630928
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)200930(10)242387
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/01/2019

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: 09/30/2020
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 242387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1