MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE,

Model Number	DBP-200SOLID145
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Code Available (3191)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned by the facility; therefore, an analysis of the actual device is not possible.Csi is requesting additional information and return of the product for analysis and will submit a supplemental report, if received.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 via medwatch (uf/importer report # (b)(4)) that during a peripheral orbital atherectomy procedure, a dissection and no flow event occurred.The target lesion was located in the right superficial femoral artery (sfa).The physician advanced the csi oad to the treatment area and completed the intervention.Upon removal of the device, the physician felt resistance, but was able to remove the device.Angiography identified that there was a dissection and no distal flow in the sfa.The physician attempted to introduce a wire to perform balloon angioplasty, but was unable to advance to the site of the dissection.The physician used doppler in an attempt to identify distal pulses in the patient's right foot, but they were absent.The patient was then transported to surgery for additional intervention.A request for additional information has been made but a response has not yet been received.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE,
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 6534859
• Report Number: 3004742232-2017-00051
• Device Sequence Number: 1148748
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)180831(10)169901
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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: 08/31/2018
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP-200SOLID145
• Device Lot Number: 169901
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 05/01/2017
• 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: 72 YR