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

Model Number	PRD-SC30-150
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Failure analysis conclusion: the stealth orbital atherectomy device (oad) was received at csi (with the viperwire engaged) for analysis.Adhered biological material was observed on the driveshaft and crown.The guide wire was removed from the driveshaft crown and tip bushing section with significant resistance.The guide wire could not be reloaded through the driveshaft.Embedded biological material was observed within the driveshaft located just proximally from the crown.The morphology of the biological material is unknown, and the exact root cause of the accumulating tissue remains unknown.Although the root cause of the accumulating tissue remains unknown, it is hypothesized that the device driveshaft became stuck on the guidewire after seizing due to the biological material accumulation.At the conclusion of the failure analysis investigation the perforation event could not be confirmed through analysis.However, the reported stuck-on-wire event was confirmed to be likely due to biological material accumulation on and inside of the driveshaft.(b)(4).
Event or Problem Description
A perforation occurred in the posterior tibial artery following use of the stealth orbital atherectomy device (oad) to treat a heavily calcified lesion.The oad became stuck on the guide wire.A covered stent was used to complete the procedure with no additional issue.The opinion of the physician was that the oad crown may have been too large for the vessel, which was about 2.0mm in diameter.

• 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; st. paul MN 55112
• MDR Report Key: 8654692
• Report Number: 3004742232-2019-00145
• Device Sequence Number: 2566869
• Product Code: MCW
• UDI-Device Identifier: 10852528005046
• UDI-Public: (01)10852528005046(17)220331(10)262788
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• 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): 05/30/2019

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: 03/31/2022
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 70056-04
• Device Lot Number: 262788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/30/2019
• 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: 72 YR