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

Model Number	DBP-125MICRO60
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.Visual examination revealed adhered biological material on the driveshaft and crown.The material prevented a guide wire from passing through the area.When tested for functionality, the oad functioned as intended.At the conclusion of the device analysis investigation, the report that the device was stuck on the wire and a dissection occurred was partially confirmed.There was no damage observed with the oad that would have contributed to the dissection event.It is possible that the biological material accumulation on the driveshaft or crown contributed to the dissection, however this could not be confirmed.The report that the device was stuck on the wire was confirmed, due to the adhered material observed which prevented a guide wire from passing through.Further examination of the area of adhered material did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulation was unknown.As the original guide wire was not returned, it could not be determined if it contributed to the reported event.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: 09004.
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of lesions in the popliteal (pt) and anterior tibial (at) arteries.Pedal access via the at was obtained.Orbital atherectomy was successfully completed in the pt and treatment was continued in the at.The oad was operated on low and medium speed without issue, however the oad stopped spinning on high speed.Per the opinion of the physician, the device was stuck on the wire.A troubleshooting attempt to spin the device off of the wire was performed but was unsuccessful.The oad and wire were removed together.An angiogram was performed and revealed a type c dissection in the at artery.Two four-minute balloon inflations were performed to tamponade the dissection.A final angiography showed that the dissection was resolved.After the procedure a pressure dressing was applied, and blood thinners were administered to ensure the dissection was resolved.The patient was reported to be fine the following day.Per the opinion of the physician, the oad may have accumulated tissue while stuck on the wire or during removal and contributed to the dissection.

• 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; saint paul MN 55112
• MDR Report Key: 10572724
• Report Number: 3004742232-2020-00280
• Device Sequence Number: 14221447
• Product Code: MCW
• UDI-Device Identifier: 10852528005206
• UDI-Public: (01)10852528005206(17)211231(10)302752
• 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): 09/23/2020

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: 12/31/2021
• Device Model Number: DBP-125MICRO60
• Device Catalogue Number: DBP-125MICRO60
• Device Lot Number: 302752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/23/2020
• 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: 64 YR
• Patient Weight: 80