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

Model Number	VPR-GW-FT14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation is in process, but is not yet completed.A supplemental report will be submitted for device analysis.Csi id # (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 30cm in length, 100% stenotic and located in the superficial femoral artery (sfa).The physician advanced a csi viperwire guide wire across the lesion and a csi orbital atherectomy device (oad) was loaded onto it.The physician completed one run with a 1.50mm solid crown oad and then continued treatment with a 2.00mm solid crown oad.While removing the oad from the patient, the tip of the guide wire broke off in the patient.The physician followed up with balloon angioplasty and stent placement in order to pin the guide wire tip against the vessel wall.The patient left the procedure in stable condition.One request for additional information has been made but none has been received.
Additional Manufacturer Narrative
Device analysis: the guide wire was returned without the original oad and saline line.Examination of the guide wire revealed that the shaft was fractured and deformed at the proximal spring tip solder bond.The shaft was also observed to be deformed and curled up near the fracture site.The spring tip was not returned for analysis.No biological material was observed on the guide wire.The fractured guide wire was sent for scanning electron microscope (sem) analysis.Sem analysis identified evidence of a torsional stress fracture.At the conclusion of the failure analysis investigation the root cause of the fracture guide wire could not be conclusively determined.The material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).

• 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: 6345978
• Report Number: 3004742232-2017-00008
• Device Sequence Number: 975638
• Product Code: MCW
• UDI-Device Identifier: 10852528005329
• UDI-Public: (01)10852528005329(17)170831(10)139220
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/20/2017

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: 08/31/2017
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 139220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/21/2017
• 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