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	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: the guide wire and original filter device were received without the oad.The initial visual and tactile examination of the guide wire did not reveal any damage that would have contributed to this event.The spring tip proximal solder bond was measured and was found to be 0.0135" diameter, indicating it is an 0.014" viperwire flextip guide wire, not an 0.018" as stated on the product labeling.Further examination revealed that the solder bonds remained intact and undamaged.Examination of the returned filter device did not reveal any damage that would have contributed to the reported event.At the conclusion of the failure analysis investigation, the root cause of the reported event was an incorrectly packaged 0.014" flextip guide wire in an 0.018" flextip guide wire package.This is the same issue as mdr 3004742232-2017-00035.(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 had advanced the viperwire guide wire and filter into the patient, and loaded a csi orbital atherectomy device onto the guide wire.The physician successfully completed atherectomy and removed the oad from the patient.The viperwire guide wire was pulled back until the distal tip was just distal to the filter.When the physician attempted to retrieve the filter with the guide wire, he was unsuccessful.The 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: 6447437
• Report Number: 3004742232-2017-00034
• Device Sequence Number: 16316980
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• 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