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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Mechanical Problem (1384); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2019
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 with a diamondback peripheral orbital atherectomy device (oad), the tip bushing of the oad fractured.The 10cm long, 85% stenosed, heavily calcified target lesion was located in the mid left anterior tibial artery, and was accessed via a femoral approach.The lesion was located in a straight segment of the artery that was 2mm in diameter.The lesion was treated with five treatment passes on low speed with the oad.After the fifth pass, the oad lost speed in a tight occlusion.It was observed that the tip bushing of the oad was in the vessel.The oad was removed from the patient, and it was confirmed that the tip bushing had fractured off and remained in the patient.A non-csi catheter was used to aspirate the tip bushing from the vessel, and no portion of the oad driveshaft was left in the patient.It was noted that the procedure was completed with standard percutaneous transluminal angioplasty.The patient was stable with normal arterial function following the procedure.
Additional Manufacturer Narrative
The reported oad was received for analysis.The oad driveshaft was fractured and deformed at the tip bushing, and the tip bushing was not returned.Scanning electron microscopy of the driveshaft fracture showed severe rotation damage and plaque embedded in the smeared surface of the filars, suggesting the device spun into something hard.The inner diameter of the driveshaft exhibited rotational damage, which is consistent with a device that had spun over an object.As the driveshaft filar faces were mechanically modified/rubbed over after the fracture occurred, the root cause of the fracture is unable to be conclusively determined.There was no indication that the weld of the tip bushing was inadequate.The damage of the driveshaft filars observed was consistant with a device that was spun into a tight, calcified lesion leading to excess stress on the driveshaft filars causing filar deformation and tip weld fracture.The oad was tested, spun at all speeds, and functioned with no abnormalities nor loss of speed observed.At the conclusion of the device analysis, the report of the driveshaft fracture was confirmed, however, the report of the device loosing speed 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: 9098254
• Report Number: 3004742232-2019-00248
• Device Sequence Number: 14136509
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)201231(10)251288
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/30/2019

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: 12/31/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 251288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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