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 Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported viperwire guide wire and oad were received for analysis and were engaged.The core wire of the guide wire was observed to be fractured and damaged.It was noted that there was significant resistance felt when attempting to remove the guide wire from the oad.There was no damage to the oad observed.Scanning electron microscopy of the fractured guide wire revealed torsional shear dimples and flattened spring tip filars from rotational damage.The guide wire core wire also showed galling with radiopaque materials, and there were also radiopaque material observed on the oad tip bushing and possibly in the inner diameter of the tip bushing.The damage of the guide wire is consistent with the guide wire spring tip being spun over with the oad.The root cause of the device becoming stuck on the wire is user error as the spring tip coils became stretched and lodged under the tip bushing which occurred when the user spun the driveshaft into the guidewire spring tip.The oad spun at all speeds with no observed abnormalities.At the conclusion of device analysis, the reported event of the oad being stuck on the guide wire was confirmed.At the conclusion of device analysis, the reported event of the oad being stuck on the guide wire was 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.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
During a procedure with a diamondback coronary orbital atherectomy device (oad), it was noted the imaging was not very good, and the oad was spun too far down on the guide wire on the second treatment pass.The oad seemed to change in pitch, and an attempt was made to remove the oad.The oad was stuck on the guide wire, and the oad and guide wire were removed together.After the devices were removed, it looked like the guide wire was unraveling.It was confirmed that there were no breaks or fractures seen on the guide wire and no portions were left in the patient.The physician's opinion was that the guide wire unraveled due to the oad spinning too far down the guide wire.The vessel was re-wired, and the procedure was completed with stenting the vessel.It was noted the patient was fine following the procedure.The viperwire guide wire was received by analysis and was found to have a fractured spring tip.The facility was unaware of the fractured spring tip.

• 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: 9069672
• Report Number: 3004742232-2019-00239
• Device Sequence Number: 16888165
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)201031(10)11042801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11042801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR