MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. 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	07/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis is in process.A supplemental report will be submitted for failure analysis results.(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 was located in the superficial femoral artery (sfa).The physician used an abbott guide wire and a quickcross 0.014" guide catheter to access the lesion.A distal filtration device was advanced into the patient distal to the lesion.The abbott guide wire was exchanged for a csi viperwire guide wire and a csi orbital atherectomy was loaded onto the guide wire.The physician performed one run at low speed, one run at medium speed and two runs at high speed.While removing the oad, the physician discovered that the tip of the guide wire had broken off.The physician was able to retrieve the filter from the patient, but the tip of the wire still remained in a branch of the peroneal artery.The wire was stented against the vessel wall to prevent it from migrating distally.The patient status remained stable throughout the procedure.
Additional Manufacturer Narrative
The guide wire was received without the original oad.The initial visual and tactile examination revealed that the spring tip was fractured 329cm distal to the proximal end of the guide wire.Further examination revealed two areas of adhered biological material on the shaft just proximal to the fractured end of the wire.Examination in the areas of adhered tissue did not reveal any damage that would have contributed to the accumulation.There was no damage observed with the guide wire that would have contributed to the event.The fractured end of the guide wire was sent for scanning electron microscope (sem) analysis.Sem analysis identified evidence of fatigue that was partially covered by mechanical damage.The fracture had a large ductile tear-off zone with some folding or creasing back onto the core wire.At the conclusion of the failure analysis investigation, the root cause of the reported event could not be conclusively determined.(b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 6794897
• Report Number: 3004742232-2017-00077
• Device Sequence Number: 16536313
• Product Code: MCW
• UDI-Device Identifier: 10852528005329
• UDI-Public: (01)10852528005329(17)190228(10)185950
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/18/2017

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: 02/28/2019
• Device Model Number: VPR-GW-FT18
• Device Catalogue Number: VPR-GW-FT18
• Device Lot Number: 185950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/19/2017
• 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
• Patient Age: 74 YR
• Patient Weight: 95