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

Model Number	PRD-SC30-200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
A stealth orbital atherectomy device (oad) was selected for treatment in the common femoral artery via 6fr access.The driveshaft of the oad broke during an attempt to advance the oad over the bifurcation.A competitor catheter was inserted in order to pull the guide wire and fragment of oad into the sheath and out of the patient.The procedure was completed with a smaller oad and angioplasty with excellent results and minimal delay.The patient was stable and was discharged without complication.
Additional Manufacturer Narrative
Device analysis results: the oad was received at csi for investigation.The oad operated as intended during functional testing.Visual examination revealed the driveshaft was fractured at the distal edge of the crown.The nose of the driveshaft was not returned.Scanning electron microscopy identified fatigue striations on the fractured filar faces.The fractured driveshaft filars are likely the result of localized, elevated stress levels applied to the driveshaft while spinning.It is hypothesized that the angle into the ostial iliac placed a tight radius bend on the guide wire and driveshaft.It is hypothesized that spinning through this location surpassed the design limits of the driveshaft.However, the exact root cause of the fracture cannot be determined.At the conclusion of the device analysis investigation, the reported driveshaft fracture 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.The device met material, assembly, and quality control requirements.Csi id: (b)(4).

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 9864873
• Report Number: 3004742232-2020-00093
• Device Sequence Number: 3183739
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)221031(10)293922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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,Followup
• Report Date (Section B): 04/21/2020

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 293922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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
• Patient Age: 82 YR