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	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
The tip of the viperwire guide wire sheared off in the distal left anterior descending artery (lad) during atherectomy.Due to the small size of the vessel, the fragment could not be recovered despite use of a snare.The tip of the wire was left in vivo, and the patient was well following the procedure.The cause of the wire fracture was that the oad was operated near the tip.
Additional Manufacturer Narrative
Medwatch (b)(4) was received by csi on 9/9/2019.The additional information received in the medwatch has been included in this report.Additionally, the device was released to the csi field representative for analysis.The device is in transit.A follow-up report will be sent after the device analysis is completed.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).
Event or Problem Description
Difficulty was encountered during delivery of the viperwire guide wire to the intended location.Atherectomy was performed, and the orbital atherectomy device (oad) was operated near the spring tip of the viperwire.The tip of the wire fractured in the distal left anterior descending artery (lad) as observed during removal of the oad with glideassist.Due to the small size of the vessel, the fragment could not be recovered despite use of a snare.The tip of the wire was left in vivo, and the patient was well following the procedure.
Additional Manufacturer Narrative
Failure analysis conclusion: the viperwire was received at csi for analysis.Examination revealed the spring tip to be fractured off.The fragment was not returned.Scanning electron microscopy analysis concluded the guide wire fractured due to excessive rotational damage; rotational dimples were observed on the fractured surface.It is hypothesized that the root cause of the fractured guide wire spring tip is user error as analysis of the fracture face is consistent with the torsional damage normally seen when the oad driveshaft is spun into the guide wire spring tip resulting in a fracture.Also, this is confirmed by details reported to csi during the investigation of the event, which indicate the user operated the atherectomy device near the viperwire spring tip.At the conclusion of the failure analysis investigation the reported event was confirmed.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 hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8921754
• Report Number: 3004742232-2019-00223
• Device Sequence Number: 11362140
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)210430(10)11100502
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/25/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11100502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/09/2019; 09/18/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/11/2019; 09/25/2019
• 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: 82 YR