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

Model Number	GWC-12325LG-FLP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/04/2019
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.Additional information regarding another csi device used in this procedure is documented in mdr 3004742232-2019-00119.Related manufacturer reference number: (b)(4).(b)(4).
Event or Problem Description
During a procedure viperwire guide wire was used during treatment of a 95% stenosed type b lesion in the left main coronary artery.The lesion was treated with five passes at 80,000 rpm.On the fifth treatment pass, the tip of the guide wire fractured because the crown of the oad jumped forward.The physician decided to abandon the wire fragment.The patient was stable following the procedure.
Additional Manufacturer Narrative
The reported guide wire was received for analysis.It was observed that the guide wire was fractured and there was surface wear visible near the fracture end.The fractured portion of the guide wire was not returned.Scanning electron microscopy of the fractured end of the guide wire revealed excessive torsional damage and stresses.Radiopaque particles were identified on the tip bushing of the oad utilized in the procedure which is consistent with the oad driveshaft having spun into the guide wire spring tip.The root cause of the fractured guide wire spring tip is hypothesized to be user error as this analysis is consistent with the oad driveshaft having spun into the guide wire spring tip and causing the fracture.At the conclusion of device analysis, the reported event of a guide wire fracture was confirmed, however, the reported event of the driveshaft jumping forward 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.Additional information regarding another csi device used in this procedure, and the analysis for the oad, is documented in mdr 3004742232-2019-00119 and mdr 3004742232-2019-00119-001.Related manufacturer reference number: (b)(4).Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8566547
• Report Number: 3004742232-2019-00118
• Device Sequence Number: 19588125
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)200531(10)11025783
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• 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): 06/07/2019

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: 05/31/2020
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11025783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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