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

Model Number DBP-125MICRO145

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Vessels (2135)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

Device analysis: the oad was returned with the guide wire engaged in the device.The initial visual and tactile examination revealed that the saline sheath was separated 8cm from the nose cone.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.After removal, examination in the area of the biological material 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 also met the drawing specification.Examination of the exposed sections of the guide wire revealed damage to the spring tip.The damage was consistent with the spinning driveshaft contacting the proximal guide wire solder bond.The guide wire was removed distally from the handle assembly with significant resistance.Examination of the remaining section of the guide wire revealed numerous kinks along the shaft.The spring tip was sent for scanning electron microscope (sem) analysis.Sem analysis confirmed evidence that the oad tip bushing contacted the spring tip during device rotation.An in-house.014 test wire was loaded through the distal end of the driveshaft, but met significant resistance in the location of the adhered biological material.The driveshaft was destructively cut to allow for functional testing.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.At the conclusion of the failure analysis investigation, the root cause of the oad becoming stuck in the patient could not be determined.Additionally, the root cause of the perforation could not be determined.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 perforation occurred while using a csi orbital atherectomy device (oad).The target lesion was 2mm in length, 80% stenotic and was located in the pedal arterial loop.The physician used a 6fr introducer sheath from an antegrade approach to access the lesion.A csi viperwire guide wire was advanced across the lesion and the oad was loaded onto it.The physician performed one run at low speed, but the oad kept bogging down.The physician turned off the oad and attempted to remove it from the patient, but discovered that it was stuck.The physician then attempted to spin the oad out of the patient, but was unsuccessful.The oad and guide wire were then pulled out of the patient with additional force.Angiography revealed a perforation in the pedal arterial loop.The physician was able to resolve the perforation and the patient status remained stable throughout the procedure.Additional information has been requested, but has not 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: 5897015
• MDR Text Key: 53440223
• Report Number: 3004742232-2016-00091
• Device Sequence Number: 1
• Product Code: MCW
• 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: 08/22/2016

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: 05/31/2018
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 161688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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