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 Codes	Vascular System (Circulation), Impaired (2572); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/13/2019
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.The returned oad analysis is included in mdr reference 3004742232-2019-00090.Csi id# (b)(4).
Event or Problem Description
A moderately calcified, 95% stenosed lesion was located in mildly tortuous area of the posterior tibial (pt) artery beyond the level of the ankle.The lesion was 3.5 cm in length and the vessel was 1.5-2 mm.The viperwire guide wire was advanced past the heel and appeared to be located in a luminal plane.The diamondback peripheral orbital atherectomy device (oad) was advanced 2-3 mm proximal to the lesion.The oad was turned on at low speed, and the crown jumped forward on the guide wire and stopped spinning.An attempt was made to remove the oad from the guide wire; however, the devices were stuck together and unable to be removed using considerable force.A non-csi guide wire was advanced in an attempt to loosen the crown from the vessel wall, but this was unsuccessful.A coronary balloon was used to attempt to create space in the removal of the device, but the device remained stuck.The saline sheath of the oad driveshaft was cut at the strain relief of the oad.The saline sheath was advanced over the crown of the oad, and the oad and guide wire were successfully removed.It was observed after the devices were removed that a portion approximately 7 cm of the spring tip of the guide wire had sheared off and remained in the distal portion of the pt.There was no attempt to snare the fractured piece of the guide wire.The cause of the guide wire fracture was unknown.Angiographic imaging was done and showed no flow into the pt, and the procedure was aborted.No additional intervention was planned with the patient after the procedure beyond normal surgical follow-ups.There was no intervention planned or scheduled to remove the guide wire fragment that remained in the patient.Note: the event including the oad information can be found in mdr reference 3004742232-2019-00090.
Additional Manufacturer Narrative
The reported guide wire was received at csi for analysis.A visual examination confirmed that the spring tip had been fractured off, and the distal fractured spring tip section was not returned.A kink in the guide wire located 162.5cm from the proximal end was also observed.Scanning electron microscopy of the fractured portion of the guide wire was performed and identified evidence of ductile shear dimples with a cup and cone break.This is likely due to tensile forces exceeding the design limits of the guide wire.Radiopaque particles were also found on the tip bushing of the oad, indicating the oad came into contact with the guide wire spring tip.The instructions for use (ifu) for the reported device include the following warning "when moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip and the distal end of the shaft (10 cm minimum).If the distance between the shaft tip and the guide wire spring tip is insufficient, the shaft tip may damage the guide wire spring tip and result in dislodgement of the guide wire spring tip.Use contrast injections and fluoroscopy to monitor movement of the shaft tip in relation to the guide wire spring tip." at the conclusion of the device analysis investigation, the guide wire fracture event was confirmed, however, the report of no flow in the vessel was unable to be conclusively confirmed.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: 8488455
• Report Number: 3004742232-2019-00091
• Device Sequence Number: 1928264
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)201231(10)253351
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/12/2019

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: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 253351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: Other
• Patient Age: 61 YR