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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received at csi for analysis.Visual examination revealed shipping damage to the nose cone, and some biological material on the driveshaft and crown.Examination of the area of adhered material did not reveal any damage that would have contributed to the material accumulation.The morphology and exact root cause of the accumulation was unknown.A guide wire was inserted into the oad and met resistance 3 centimeters from the driveshaft tip bushing.The driveshaft was cut proximal to the crown and the guide wire was able to advance through towards the shipping damage where resistance was met again, and the shipping damage was removed.The oad was powered on and off multiple times and performed on both speeds without any issues observed.The power cord, brake and control knob were manually manipulated with no abnormalities observed.The oad functioned as intended.At the conclusion of the reported event that the oad stopped spinning, and upon removal a perforation was noted could not be confirmed through analysis.Analysis revealed some adhered biological material on the driveshaft and crown that prevented the guide wire from passing through and may have contributed to the reported issue, but this was not confirmed.The root cause of the perforation and accumulated tissue could not be determined.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.Additional information regarding the event description has been requested, but has not yet been provided.If additional information is received a supplemental report will be submitted.
Event or Problem Description
During a procedure, the peripheral diamondback orbital atherectomy device (oad) stopped spinning and a perforation was noted after removal of the oad.The oad was operated for one second when it stopped spinning, and was difficult to remove.Once the oad was removed an unknown material was observed on the crown and a perforation was noted.Balloon angioplasty was performed in order to attempt to resolve the perforation but the patient outcome is unknown.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 9083080
• Report Number: 3004742232-2019-00244
• Device Sequence Number: 11426207
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210430(10)267366
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/18/2019

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: 04/30/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 267366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/18/2019
• 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: Required Intervention