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

Model Number	DBP-200SOLID145
Medical Device Problem Codes	Detachment Of Device Component (1104); Entrapment of Device (1212); Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received for analysis with the guide wire.The crown driveshaft section of the oad was found to be detached and the guide wire was received with a detached spring tip.The spring tip fragment was not received for analysis and no stent fragments were noted on the returned devices.Scanning electron microscopy (sem) was performed on the driveshaft and found fatigue on multiple filars as well as evidence that filars had been destructively cut.The driveshaft was found to be overloaded at the lap weld, indicating that the device experienced some form of resistance while spinning.This may have been the result of spinning inside a stent, though this could not be confirmed.The sem analysis also found evidence of torsional overload on the fractured guide wire.Target lesions located inside a stent are contraindicated per the peripheral oad ifu.At the conclusion of the device analysis investigation, the reported device detachment was confirmed.However, the root cause of the detachment was unable to 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.The material inspection report for the guide wire was unable to be reviewed, as the lot number was not provided.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), the device became detached and caught on a stent.The target lesion was located in the iliac and was highly calcified.Following the first pass with the oad, the device became detached and the driveshaft and guide wire became caught in a previously placed stent.One portion of the device was retrieved with a snare, and balloon angioplasty was performed.An additional portion of the detached device along with the remainder of the stent were removed surgically.The patient was discharged the following day in stable condition.

• 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: 7568937
• Report Number: 3004742232-2018-00153
• Device Sequence Number: 14085128
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)200131(10)215703
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/05/2018

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: 01/31/2020
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 215703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/05/2018
• 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