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

Model Number	DBP-125SOLID145
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad and guidewire were returned for evaluation.The initial visual and tactile examination of the handle assembly, saline sheath, and driveshaft revealed the saline sheath and driveshaft to have been cut from the handle assembly.Further examination did not reveal any damage that would have contributed to the reported event.The initial visual and tactile examination of the guide wire revealed the spring tip to have been fractured off at the proximal solder bond.The proximal solder bond exhibited damage consistent with the driveshaft tip bushing having come into contact with the spring tip.The control knob traveled smoothly and the remaining driveshaft section could be seen moving at a 1:1 ratio with the movement of the control knob.An in-house test wire was loaded through the device without resistance.The oad speeds were tested and the device spun during all three speeds low, medium, and at high with no abnormalities observed.The device was turned on and off numerous times with no issues observed.Based on the device analysis, the root cause of the reported event could not be confirmed.
Event or Problem Description
It was reported that during a peripheral orbital atherectomy procedure, a perforation occurred and a portion of the wire became detached.When the csi orbital atherectomy device (oad) was advanced to treat a heavily calcified lesion, the crown became stuck in the lateral plantar artery and the tip of the guidewire became detached.A non-csi catheter and guidewire, and balloon were inserted, however the balloon was unable to be advanced around the heel bend.Imaging was performed and a perforation was noted.Surgery was completed to remove the oad and the guidewire tip, and a bypass was performed.The patient was stable 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 hwy 8 nw; saint paul MN 55112
• MDR Report Key: 7045511
• Report Number: 3004742232-2017-00133
• Device Sequence Number: 1901460
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)190630(10)195040
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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: 06/30/2019
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 195040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/20/2017
• 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