MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE, PRODUCT CODE: MCW

Model Number	DBP-125SOLID145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided to csi, it was determined that the perforation was caused by a non-csi device.The issue reported with the csi device, however, did lead to a significantly longer procedure time, so a report was made.Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
During a procedure with a diamondback peripheral orbital atherectomy device (oad) the motor reportedly did not fully engage when the physician attempted to increase the speed to medium in a 100% stenosed lesion in a 3 mm area of the mid to distal post tibial artery.The device was turned to low and back to medium, but the issue recurred.The device was stuck on the wire and both the device and wire were removed from the patient.When the physician attempted to rewire the vessel using a non-csi guide wire, a perforation in a collateral vessel occurred.A balloon was used, the physician was able to introduce blood flow to the foot through the post tibial artery, and the patient was doing well following the procedure.
Additional Manufacturer Narrative
The reported oad was received for analysis along with the guide wire utilized during the procedure.Adhered biological material was also observed on both the oad and guide wire sections.Upon examination, the proximal spring tip coil of the guide wire was damaged, deformed and stretched distally but remained intact with no fractures observed.The guide wire was removed from the distal driveshaft section with some resistance.The oad was found to spin at all three speeds with no abnormailities or unusual noises observed.At the conclusion of the device analysis investigation, the event could not be conclusively confirmed through analysis.(b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE, PRODUCT CODE: MCW
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8151538
• Report Number: 3004742232-2018-00364
• Device Sequence Number: 2124930
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)200930(10)240005
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• 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): 12/20/2018

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: 09/30/2020
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 240005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 91