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

Model Number	VPR-GW-FT18
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis: the guide wire was returned without the original oad or saline line.The initial visual and tactile examination revealed that the spring tip was fractured off 330.4cm distal to the proximal end.The guide wire shaft was curled up at the fracture site and the fractured spring tip was not returned.No biological material was observed on the shaft of the guide wire.At the conclusion of the failure analysis investigation, the root cause of the fractured guide wire could not be conclusively determined.(b)(4).
Event or Problem Description
It was reported that during a peripheral orbital atherectomy procedure, the tip of a csi viperwire guide wire broke off and was left in the patient.The target lesion originated in the tibio-peroneal trunk (tpt) and extended into the posterior tibial (pt) artery.The physician used a 6fr introducer sheath and a 0.014 glidewire guide wire to access the lesion.The glidewire was exchanged for the csi viperwire guide wire and a csi orbital atherectomy device (oad) was loaded onto the wire.As the oad was being advanced over the guide wire, the physician observed that the tip of the guide wire was within the oad driveshaft.The guide wire was advanced distally and the oad was then advanced further.However, the physician again observed that the tip of the guide wire was within the oad driveshaft.The oad was removed, but while re-positioning the guide wire, the physician noted that the tip had broken off and migrated distally.The physician exchanged the viperwire for a 0.014 nitrex guide wire and advanced a stent over it.The stent was deployed in the area of the broken viperwire tip in order to pin it against the vessel wall.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: 5667364
• Report Number: 3004742232-2016-00040
• Device Sequence Number: 18940552
• Product Code: MCW
• UDI-Device Identifier: 10852528005329
• UDI-Public: (01)10852528005329(17)170731(10)137021
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

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: 07/31/2017
• Device Model Number: VPR-GW-FT18
• Device Catalogue Number: VPR-GW-FT18
• Device Lot Number: 137021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2016
• Initial Report FDA Received Date: 05/19/2016
• 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; Required Intervention
• Patient Age: 74 YR