MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number VPR-GW-FT14

Device Problem Material Separation (1562)

Patient Problem Perforation of Vessels (2135)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

The reported guide wire was received for analysis.Examination of the guide wire revealed the proximal core wire to be fractured.The distal spring tip section revealed the distal and proximal solder bonds to be intact and undamaged, while the spring tip coils were noted to be damaged and deformed.There was no adhered biological material on the guide wire shaft or spring tip.There was no other damage revealed with the guide wire that would have contributed to the reported event.Scanning electron microscopy revealed the presence of torsional stresses on the fracture face of the core wire.At the conclusion of the device analysis investigation, the root cause of the guide wire fracture and if it contributed to the reported perforation was unable to be confirmed.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).

Event Description

During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a perforation occurred and the guide wire was damaged.The target lesion was located in the popliteal artery and was treating using one pass with the oad at low speed, one pass at medium speed and one pass at high speed.Balloon angioplasty was performed following treatment with the oad, and a perforation was noted above the location of the guide wire.Pressure was applied to the exterior of the leg, and the perforation resolved with no additional intervention.When the guide wire was removed from the patient, the tip was noted to be frayed.Upon examination by the hospital staff, the tip of the wire became detached outside the patient.The patient was stable following the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 7309949
• MDR Text Key: 101391284
• Report Number: 3004742232-2018-00043
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)190731(10)200749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 200749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention