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

Model Number	DBEC-125M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad and guide wire were received for analysis.The driveshaft and guide wire spring tip exhibited adhered biological material.Examination in the areas of the adhered tissue did not reveal any damage that would have contributed to the accumulation.The driveshaft crown and distal tip bushing bulb were analyzed using scanning electron microscopy (sem), which did not reveal any damage or abnormalities that would have contributed to a perforation.When tested, the device functioned as intended and spun during both speeds with no abnormalities observed.At the conclusion of the analysis investigation, the reported event was not able to be confirmed.The oad and guidewire did not exhibit any abnormalities that could have caused a perforation.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.(b)(4).
Event or Problem Description
During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), a perforation occurred.The target lesions were 70% stenosed and located in the proximal right coronary artery.After treatment of the first lesion, the device stopped functioning and was not able to be removed from the vessel.The device was spun out of the vessel into the guide catheter.The pressure of the patient began to drop, and imaging revealed a perforation.An echocardiogram and pericardiocentesis were performed, and the vessel was re-wired to perform balloon angioplasty.An attempt was made to place a stent, however the stent was unable to reach the site of the perforation.The procedure was aborted and the patient was stable following the procedure.

• 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: 7114370
• Report Number: 3004742232-2017-00155
• Device Sequence Number: 11245956
• Product Code: MCX
• UDI-Device Identifier: 10852528005336
• UDI-Public: (01)10852528005336(17)180131(10)199849
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/13/2017

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: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: DBEC-125M
• Device Catalogue Number: DBEC-125M
• Device Lot Number: 199849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/13/2017
• 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: 76 YR