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

Model Number DBP-125MICRO145

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

Device analysis: the oad was received without the original guide wire.The initial visual and tactile examination revealed a kink in the driveshaft 18.5cm distal to the nose cone.It could not be determined whether or not the damage occurred during the procedure or as a result of being returned to csi without the protective tray.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.Examination in the area of the adhered tissue did not reveal any damage that would have contributed to the accumulation.The outside diameter (od) of the crown was measured using a calibrated dial caliper and met the drawing specification.The placement of the crown and driveshaft dimensions also met the drawing specifications.An in-house 0.014" wire was loaded through the driveshaft, but met resistance at the location of the driveshaft kink.The kink was destructively removed to allow for functional testing.The guide wire was then loaded through the handle assembly without resistance.When the device was powered on, the led's on the handle assembly illuminated and defaulted to the low speed led as expected.When tested on low speed using a test fixture, the device was unable to reach 60k rpms and only reached 35k rpms.The device was then tested at medium and at high speed and would not exceed 35k rpms.Additional electrical analysis revealed that the device was continuously drawing the maximum current limit, but the speed would not exceed 35k rpms.At the conclusion of the failure analysis investigation, the motor was observed to only operate at 35k rpms, but the root cause could not be conclusively determined.The motor has been sent to the vendor for additional electrical analysis.The root cause of the dissection also could not be determined.Additionally, it could not be determined whether or not the oad motor operating at a lower rpm was related to the dissection.A driveshaft that cannot get to speed results in a delay of therapy.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.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a dissection occurred while using a csi orbital atherectomy device (oad).The target lesion was 14cm in length, 99% stenotic, and was located in the superficial femoral artery (sfa).The physician used a 6fr introducer sheath and 6fr ansel guide catheter to access the lesion.The physician advanced a csi viperwire guide wire across the lesion and the oad was loaded onto it.The physician successfully completed two runs at low speed and two runs at medium speed.During the next run at high speed, the device did not sound as if it were reaching the appropriate rpms.The physician was able to complete the final run at high speed; however, the oad sounded as if it were spinning at lower rpms.The device was removed from the patient and angiography revealed a dissection.The physician deployed a 6mm balloon and 6mm stent to resolve the dissection.The patient left the procedure in stable condition.Three requests for additional information have been made, but none has yet been received.

• Brand Name: DIAMONDBACK 360 PERIPHERAL 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: jacob mellem ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 6042079
• MDR Text Key: 57917343
• Report Number: 3004742232-2016-00116
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)180531(10)162407
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 162407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2016
• 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