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

Model Number DBP-125MICRO145

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Vessels (2135)

Event Date 04/21/2016

Event Type  Injury  

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, saline sheath, and driveshaft did not reveal any damage.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 this area 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.The initial visual and tactile examination of the exposed distal and proximal guide wire sections did not reveal any damage.Further examination revealed that the spring tip and the distal and proximal solder bonds remained intact and undamaged.No biological material was observed on the spring tip or exposed shaft sections.Resistance was met when removing the guide wire distally from the handle assembly at the location of the biological material.The returned guide wire was loaded through the device and passed through without issue.When tested, the device 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, but none were found.The device and components functioned as intended with no abnormalities 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 device becoming stuck on the guide wire could not be conclusively determined.The root cause of the perforation could not be determined.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a perforation occurred while using a csi orbital atherectomy device (oad).The target lesion was 60mm in length and was located in the peroneal artery.The physician accessed the lesion using a 6fr introducer and a csi viperwire guide wire.The oad was loaded onto the guide wire and two low speed runs were performed for a total run time of 30 seconds.During the second run, the device locked down on the guide wire and stopped spinning.The physician removed the oad and guide wire as a unit.Post-atherectomy angiography revealed a perforation.The physician resolved the perforation via balloon angioplasty.The patient status remained stable throughout the procedure.Csi contacted the facility medical records department to obtain additional information, but could not do so as the patient name is not known.

• Brand Name: DIAMONDBACK 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: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 5657766
• MDR Text Key: 45257058
• Report Number: 3004742232-2016-00038
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)170228(10)152486
• 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: 05/16/2016

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: 02/28/2017
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 152486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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): Required Intervention