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

Model Number	VPR-GW-FT14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/24/2019
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 viperwire broke.The target lesion was 120 mm long and located in the right superficial femoral artery.The lesion was severely calcified, and the vessel was 100% obstructed.After two passes on low speed and three passes on medium speed, the guide wire seemed to kink.After atherectomy had been completed, the guide wire was not moving independent of the oad.After the guide wire and oad were removed from the patient, it was observed that the spring tip of the guide wire remained in the vessel.An attempt was made to snare the fragment, and the fragment was seized on the first try and removed from the patient.Following the fragment removal, the procedure was completed with balloon angioplasty.The result of the procedure was great blood flow through the lesion and to the foot.The patient was doing well following the procedure and was discharged the next day.
Additional Manufacturer Narrative
The reported oad and guide wire were received for analysis.The driveshaft and nosecone of the oad were damaged from some form of impact, likely from shipping damage.Adhered biological material was observed on the oad crown.The morphology and exact root cause of the accumulated biological material is unknown.Upon examination of the driveshaft, the driveshaft filars were deformed and overloaded.This type of damage is indicative of the device experiencing some form of resistance while spinning, however the exact cause of the damage could not be determined.The crown and distal tip bushing was noted to be undamaged.The oad was found to operate at all three speeds with no abnormalities or unusual noises observed.It was observed the guide wire was fractured, and the fractured spring tip was returned.Scanning electron microscopy revealed torsional stresses and ductile dimples on the fracture faces of the core wire.The root cause of the damage is unknown, however, this damage is consistent with spinning over a tight bend or king in the wire.At the conclusion of the device analysis investigation, the reported event of the broken guide wire was 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: 8345287
• Report Number: 3004742232-2019-00054
• Device Sequence Number: 1833229
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)190831(10)203078
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151260
• 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): 02/28/2019

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: 08/31/2019
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 203078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 02/28/2019
• 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: 78 YR