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	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.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
It was reported that during a coronary orbital atherectomy procedure, a perforation occurred while using a csi orbital atherectomy device (oad).The target lesion was 99% stenotic and was located in the mid left anterior descending (lad) artery.The physician used an 8fr introducer sheath, ebu guide catheter and a workhorse guide wire to access the lesion.The physician exchanged the workhorse guide wire for a csi guide wire and loaded the oad onto it.The physician performed ten runs at low speed for 15 seconds each run.The physician then performed three runs at high speed for 25 seconds each run.Post-atherectomy angiography revealed a perforation.The physician resolved the event via balloon angioplasty and then performed pericardiocentesis.The patient status remained stable throughout the procedure.The device was discarded and is not available for analysis.

• 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: 6907813
• Report Number: 3004742232-2017-00098
• Device Sequence Number: 10987782
• Product Code: MCX
• UDI-Device Identifier: 10852528005336
• UDI-Public: (01)10852528005336(17)171231(10)197993
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

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: 12/31/2017
• Device Model Number: DBEC-125M
• Device Catalogue Number: DBEC-125M
• Device Lot Number: 197993
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/02/2017
• 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: 55 YR