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

Model Number	VPR-GW-FT18
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Compatibility Problem (2960); Incorrect Device Or Component Shipped (2962)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The guide wire was discarded by the facility and an exact root cause could not be determined.The lot number was initially unknown, but an internal review for this customer identified that the previous two orders of 0.018" flextip guide wires were lot number 156032.A review of lot number 156032 identified that a recall had been initiated for an incorrectly packaged 0.014" flextip guide wire in an 0.018" flextip guide wire package.This is the same issue as mdr 3004742232-2017-00034.(b)(4).
Event or Problem Description
It was reported that during a peripheral orbital atherectomy procedure, an abbott nav6 embolic protection device slid off the end of a csi 0.018" viperwire guide wire when removing it from the patient.The physician successfully completed atherectomy, but it was noted that the distal tip of the oad was being brought into contact with the filter during treatment.When the physician attempted to retrieve the filter with the guide wire, he was unsuccessful.The viperwire guide wire was removed from the patient and the physician was then able to retrieve the filter with a snare device.The patient status remained stable throughout the procedure.

• 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: 6447444
• Report Number: 3004742232-2017-00035
• Device Sequence Number: 1042775
• Product Code: MCW
• UDI-Device Identifier: 10852528005329
• UDI-Public: (01)10852528005329(17)180228(10)156032
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K151260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

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: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: VPR-GW-FT18
• Device Catalogue Number: VPR-GW-FT18
• Device Lot Number: 156032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/30/2017
• 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: Other