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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Perforation (2001); Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device analysis results: the oad was returned to csi for analysis with the guide wire not engaged in the device.Analysis revealed biological material embedded within the driveshaft filars near the crown; this prevented the guidewire from passing through during testing, which may confirm the report that the device became stuck on the guide wire.Examination did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulation is unknown.The crown was measured and found to have met drawing specifications.When tested, the oad functioned as intended.The reports that the crown jumped, slow/no flow occurred, and dissection and perforation occurred were not confirmed.There was no damage or abnormalities observed with the driveshaft or handle that would have contributed these reported issues.The opinion of the physician was that the device contributed to the reported events, though the perforation occurred as a result of angioplasty used to address the reported dissection.Csi id: (b)(4).
Event or Problem Description
Treatment was performed via left femoral access with a diamondback peripheral orbital atherectomy device (oad) in the popliteal and proximal anterior tibial artery (at), each of which was 80% stenosed.The vessel diameter was 3mm, and the lesions were moderately calcified.The proximal at lesion was treated on low, medium, and high speed for 15 seconds each.During the final treatment, the user felt the device jump backwards, and the device became stuck on the guide wire.The use of glideassist did not resolve the issue.The oad and wire were removed from the patient, and the vessel was rewired.Angiography showed no flow in the vessel and a dissection in the proximal at.Angioplasty was performed.Thereafter, a perforation was observed.The balloon was reinserted and inflated for five minutes.The procedure was delayed by 30 minutes or more due to time taken to rewire the vessel.The patient was stable with no complaint of pain.

• Brand Name: DIAMONDBACK 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: 11962244
• Report Number: 3004742232-2021-00208
• Device Sequence Number: 11648471
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)220731(10)338154
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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: 07/31/2022
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 338154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/08/2021
• 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