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

Model Number	PRD-SC30-200
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/08/2019
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
The stealth orbital atherectomy device (oad) sheath became stuck in the iliac bifurcation, and the driveshaft became stretched.The iliac bifurcation had a narrow diameter.Additional access was obtained on the opposite side to push the device back, and the oad was able to be removed.No fractures occurred, and the procedure time was extended by almost an hour.
Additional Manufacturer Narrative
The device was received at csi for analysis.There was no crown or driveshaft damage or abnormality that appeared to have contributed to the device becoming stuck.Visual examination revealed multiple areas of damage to the driveshaft, sheath and guidewire that likely occurred during attempts to remove the stuck device.Further examination of the driveshaft revealed filar deformation.The driveshaft had been destructively cut with the wire engaged.The driveshaft damage was destructively removed to allow for functional testing, and the device functioned as intended.The distal end of the guide wire appeared to have been pulled to failure with the spring tip not having been returned.Scanning electron microscopy analysis revealed the fracture face to exhibit damage due to stretching and tensile forces.Per additional details reported to csi, this guide wire fracture occurred outside the patient.At the conclusion of the failure analysis investigation, the reported events were partially confirmed.Although the root cause of the stuck device is undetermined, the device damage appears to be the result of attempts at removing the stuck device from the introducer sheath.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 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: 8959719
• Report Number: 3004742232-2019-00234
• Device Sequence Number: 16744102
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)220531(10)273387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/26/2019

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: 05/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 273387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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
• Patient Age: 76 YR
• Patient Weight: 68