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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
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.Csi id# (b)(4).
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was used to treat a heavily calcified, 100% occluded lesion in the anterior tibial artery (at) that was approximately eight (8) cm in length.The vessel was approximately 2.5 to 3 mm in diameter and was not tortuous.The lesion was crossed via tibiopedal access and the oad was used via a femoral access.The lesion was treated with four (4) treatment passes with the oad.When attempting to remove the oad, the crown became stuck at the ostium of the at.Attempts were made with balloon angioplasty to free the crown, however, these attempts were unsuccessful.A catheter was inserted via the tibiopedal access point and passed over the oad crown, and the oad was then able to be removed successfully.The procedure was completed with percutaneous balloon angioplasty, and no stent was required at the location the oad crown had become stuck.The patient was doing well following the procedure, and flow had been established through the anterior tibial artery.It was noted that the patient would have additional revascularization in the future.
Additional Manufacturer Narrative
The oad was received for analysis.Adhered biological material was observed on the driveshaft and crown, and examination did not reveal any damage that would have contributed to the accumulated material.The morphology and exact root cause of the accumulation is unknown.A guide wire was passed through the device and met slight resistance passing through the area of adhered material.The oad was tested, spun at all speeds, and functioned as intended.At the conclusion of device analysis, the reported event of the crown becoming stuck in the vessel was unable to be conclusively confirmed.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# (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: 8818193
• Report Number: 3004742232-2019-00192
• Device Sequence Number: 14162782
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210430(10)265436
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 265436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/01/2019
• 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