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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad and guidewire were returned for analysis.Detailed analysis revealed the guidewire to be fractured and the saline sheath and driveshaft to be damaged in multiple locations.This type of damage is an indication that the device had experienced some form of resistance while spinning during the procedure, however the exact cause of the damage could not be determined.The damaged sections of the driveshaft and guidewire were sent for scanning electron microscope (sem) analysis.Sem analysis identified the presence of torsion and torsional fatigue on the fractured filars and torsion, wear, and high-stress cracking on the fractured guidewire.At the conclusion of the device analysis investigation, the reported event was confirmed.However, the root cause of the event was unable to be determined.(b)(4).
Event or Problem Description
During a peripheral orbital atherectomy procedure using a csi orbital atherectomy device (oad), it was reported that the tip of the guidewire detached and remained in the patient.After treatment of three target lesions, the device was difficult to remove over the guidewire.When the device and guidewire were removed, it was noted that the tip of the guidewire had become detached and remained in the patient.The procedure was completed with balloon angioplasty and the patient was stable.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; saint paul MN 55112
• MDR Report Key: 7068644
• Report Number: 3004742232-2017-00144
• Device Sequence Number: 126405
• Product Code: MCW
• UDI-Device Identifier: 10852528005046
• UDI-Public: (01)10852528005046(17)190331(10)154587
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 154587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/29/2017
• 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