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

Model Number PRD-SC30-125

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

The oad was retained by the facility; therefore, an analysis of the actual complaint device could not be performed.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.Additionally, the saline infusion pump was returned to determine if there were any causing or contributing factors to the reported event of the device becoming stuck and requiring surgical removal.The saline pump was returned with the original saline bag weight sensor and power cord.The initial visual examination did not reveal any damage or abnormalities that would have contributed to the reported event.Further examination revealed that the power cord remained intact and undamaged.The pump was initially functionally tested using a test fixture that simulated the electrical load of an oad.During testing, the pump functioned as intended with no abnormalities observed.An in-house oad was then connected to the pump and tested for functionality.When tested, the oad spun at low, medium and at high speed with no abnormalities observed.While the pump motor was running, the oad was unplugged from the pump.The green pump light remained illuminated and the pump continued to run.The oad was then plugged back into the pump while it was running and the green pump light reverted back to yellow (stand-by) while the pump continued to run as intended.This is a known, confirmed response from the saline pump.The in-house oad power cord was inserted into the saline pump power jack.The power cord was then pulled and retracted from the power jack with little resistance met.A hand held calibrated tensile tester was used to test the power cord to power jack retention forces.Five pull tests in different orientations were performed.The average retention force did not appear to be sufficient enough to hold and retain the oad power cord within the saline pump power jack.At the conclusion of the saline pump failure analysis investigation, no abnormalities were noted that would have caused or contributed to the device becoming stuck in the patient.It should be noted that testing did find an insufficient retention force in the saline pump power jack, but no abnormalities were found during the analysis related to this event.The root cause of the device becoming stuck in the patient could not be determined.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a csi orbital atherectomy device (oad) got stuck in the patient and had to be surgically removed.The target lesion was located in the anterior tibial (at) artery.The physician performed multiple runs at low speed using the csi oad.During the final run, the oad made a high pitched noise and the csi saline infusion pump (sip) switched to stand-by.The physician attempted to remove the device to perform angiography, but discovered that it was stuck.After multiple unsuccessful removal attempts, the patient was taken to the operating room for surgical removal of the oad.The patient status remained stable throughout the procedure.The oad was retained by the facility, but the saline infusion pump was returned for analysis.Requests for additional information were made, but were denied by the facility due to internal policies.

• 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: 5112129
• MDR Text Key: 27051182
• Report Number: 3004742232-2015-00065
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)180430(10)125265
• 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
• Report Date: 09/23/2015

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-SC30-125
• Device Catalogue Number: PRD-SC30-125
• Device Lot Number: 125265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention