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

Model Number PRD-SC30-150

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

The device evaluation has begun, but is not yet completed.A supplemental report will be submitted containing the device failure analysis.This mdr is being submitted late.An issue occurred when renewing the signing certificate for the fda gateway.(b)(4) was completed with the esg helpdesk for this.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, the tip of a csi orbital atherectomy device (oad) broke off and required surgical removal.The target lesion was 50% stenotic and was located in the anterior tibial (at) artery.The physician used a 6frx45cm introducer sheath and a stiff glide guide wire to access the lesion.The stiff glide wire was exchanged for a csi viperwire guide wire and the oad was loaded onto it.The physician completed three runs at low speed for 25-30 seconds total.During the final run, the oad seemed to bog down and stopped spinning.The physician attempted to pull back the oad and remove it, but it was stuck in the patient.The driveshaft was cut at the point where it exited the introducer sheath outside the patient and the patient was transferred to the operating room for surgical removal.The patient status remained stable throughout the procedure.Three requests for additional information have been made, but none has yet been received.

Manufacturer Narrative

Device analysis: the oad was returned with the original guide wire engaged in the device.The initial visual and tactile examination of the handle assembly and saline sheath revealed that the nose cone assembly was damaged as a result of some form of impact, possibly from being shipped back without the protective product tray.The guide wire was bent at this location and is not considered a contributing factor to the difficulties experienced during the procedure.Continued examination of the handle assembly and saline sheath revealed that the driveshaft had been destructively cut from the oad 50cm distal to the nose cone assembly.The detached distal driveshaft section was also returned, but without the crown and tip bushing sections, which had been destructively cut from the driveshaft.The saline sheath exhibited numerous area of axial compression damage.Examination of the exposed sections of the guide wire did not reveal any damage that would have contributed to the event.Significant resistance was met when removing the guide wire from the driveshaft and handle assembly.Examination of the remaining section of the guide wire revealed numerous kinks which were located within the handle assembly and the distal cut sections of the driveshaft.It could not be conclusively determined whether or not the kinked guide wire sections contributed to the reported event.It should be noted that the distal guide wire section and spring tip had been destructively cut and not returned for analysis.Analysis of the handle assembly identified that the driveshaft separation site was at the driveshaft lap weld, which is located at the distal end of the driveshaft hypotube.The driveshaft was detached from the handle assembly while still engaged in the saline sheath.The driveshaft filars were severely elongated at the fracture site.Further examination of the driveshaft section revealed a significant amount of adhered dried biological material on the driveshaft filars.An additional saline sheath and driveshaft segment were returned and measured 62.5cm in length.The ends appeared destructively cut with 2 fractured filars in the middle of the segment.Following the optical examination, the drive shaft hypotube adapter and fractured driveshaft filars were examined in a scanning electron microscope (sem).Sem analysis did not identify any damage or abnormalities with the adaptor hypotube that would have contributed to the drive shaft fracture.Additional examination of the handle assembly revealed that the guide wire hypotube support, output gear, and bearing were dislodged.The dislodged output gear is likely due to the shipping damage back to csi and will not be considered a contributing factor to the reported event.The guide wire hypotube support, bearing, and output gear were replaced to their normal positions to allow for functional testing.An in-house.014" test wire was loaded through the device without resistance.When tested, the oad spun at low, medium and at high speed with no abnormalities observed.The device was turned on and off numerous times with no issues observed.While performing functional testing the power cord, brake, and control knob were manually manipulated to determine if there were any functional concerns with the components that would have contributed to the reported event.The device and components functioned as intended with no abnormalities or unusual sounds observed.The device history record for this oad 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.At the conclusion of the failure analysis investigation, the root cause of the fractured device and resultant surgical intervention could not be conclusively determined.(b)(4).

• Brand Name: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 5450716
• MDR Text Key: 38656547
• Report Number: 3004742232-2016-00005
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005046
• UDI-Public: (01)10852528005046(17)180430(10)126828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

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
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: PRD-SC30-150
• Device Lot Number: 126828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• 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): Required Intervention