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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Vascular Dissection (3160); No Code Available (3191)
Date of Event	04/17/2019
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
During a procedure for a patient with critical limb ischemia, the diamondback peripheral orbital atherectomy device (oad) was used to treat diffuse lesions.The patient had diffusely diseased lesions throughout the posterior tibial artery (pt), anterior tibial artery (at), and pedal loop arteries.The calcification of the lesions were moderate to severe with 75-95% stenosis depending on the area.The pt was treated with non-csi directional atherectomy, and then the entire diseased area was wired.Orbital atherectomy with the csi oad was used in the pt, and on the third treatment pass, the crown of the oad became stuck in a lesion in the plantar vessel distal to the treatment area and stopped spinning.It was noted that there was quite a bit of vessel spasms occurring during the procedure.The driveshaft and saline sheath of the oad were cut, and a non-csi catheter was used to remove the oad from the vessel.After the oad was removed, angiographic imaging was performed and a large dissection was observed affecting a long section of the lateral plantar artery.It was unknown if the dissection occurred before or after the removal of the oad.No additional intervention was performed related to the dissection.Balloon angioplasty was used to complete the procedure, and the procedure was deemed successful through ultrasound and pulsations observed in the foot indicating the patient was revascularized.The patient left the procedure in good status.
Additional Manufacturer Narrative
The reported oad and guide wire were received engaged for analysis.The driveshaft, saline sheath, and guide wire were observed to be destructively cut near the lap weld of the oad.Adhered biological material was observed on the oad crown and shaft.The morphology and exact root cause of the accumulated biological material is unknown.The oad was tested and spun at all speeds with no abnormalities observed.At the conclusion of device analysis, the report that the crown becoming stuck in the lesion and stopped spinning and vessel spasms and a dissection occurred were unable to be conclusively confirmed through analysis.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.The material inspection report for this guide wire 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: 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: 8579085
• Report Number: 3004742232-2019-00123
• Device Sequence Number: 1537615
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)201130(10)248308
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/10/2019

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: 11/30/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 248308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: 60 YR
• Patient Weight: 99