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

Model Number	RAD-SC30-175
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively 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 prior to distribution.(b)(4).
Event or Problem Description
A stealth peripheral radial orbital atherectomy device (oad) was used to treat lesions in the superficial femoral and posterior tibial arteries with no issues.The oad was then advanced to treat a small and heavily calcified area of the anterior tibial artery.One treatment pass was performed at low speed, however as the oad was advanced it stopped spinning and became stuck in the vessel.Multiple troubleshooting attempts were performed, including administration of nitroglycerin, application of a warm compress and creation of alternate access sites, however the device was unable to be retrieved.The patient was transferred to a hospital and a surgical procedure was performed to remove the oad.The oad was found to be outside of the vessel, resulting in vessel ligation.The patient was in stable condition following the surgical procedure.

• 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; st. paul, mn, mn
• MDR Report Key: 10093916
• Report Number: 3004742232-2020-00147
• Device Sequence Number: 3406388
• Product Code: MCW
• UDI-Device Identifier: 10852528005770
• UDI-Public: (01)10852528005770(17)211130(10)300464
• 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
• Report Date (Section B): 05/28/2020

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: 11/30/2021
• Device Model Number: RAD-SC30-175
• Device Catalogue Number: 7-10058-03
• Device Lot Number: 300464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: Hospitalization; Required Intervention