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

Model Number DBEC-125

Device Problem Fracture (1260)

Patient Problems Fistula (1862); Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2015

Event Type  Injury  

Event Description

It was reported that during a coronary orbital atherectomy procedure, the tip of a csi coronary viperwire guidewire fractured off and was left in the patient.The target lesion was located in the circumflex artery.The physician used a 6fr introducer sheath, pt2 crossing wire, whisper crossing wire to access the lesion.The whisper wire was exchanged for a csi coronary guidewire and a csi orbital atherectomy device (oad) was loaded onto the guidewire.The physician performed four runs at low speed, but was unable to cross the lesion.The patient woke up and started moving, which caused a loss in guidewire position.The physician re-advanced the guidewire into position and performed one run at low speed.During the run, the device made an abnormal sound.When the physician started to remove the oad and guidewire, he discovered that the tip of the guidewire had fractured off.Initially, a perforation had been noted, but after administering prodamine and re-evaluating, it was determined that there was an arteriovenous fistula (avf).The guidewire tip was not retrieved and was left in the patient.The patient status remained stable throughout the procedure and left the room in stable condition.

Manufacturer Narrative

Device analysis.The oad was returned with the original guidewire.Initial evaluation of the oad revealed adhered biological material on the crown and driveshaft.The tip bushing was missing from the distal end of the driveshaft and was not returned.The driveshaft was sent for scanning electron microscope (sem) analysis.Sem analysis identified material wear on the distal end of the driveshaft filars.Initial evaluation of the guidewire identified a fracture in the guidewire core at the distal end.The missing segment was 3.8cm in length and was not returned.The fracture was 1.3cm proximal to the proximal end of the spring tip.The guidewire had severe grind marks and wear near and at the fracture location.An in-house.012" test guide wire was loaded through the oad driveshaft and resistance was met near the crown due to the biological material.The biological material was pushed out of the driveshaft and the guidewire was loaded through the device.When tested, the device did not spin as intended.The oad motor cap was removed and moisture was found on the motor pcba.The device was unable to spin properly due to the moisture causing a short between the hall sensors.Corrective actions have been initiated to address moisture in the oad motor.The device history record for this oad lot number and the material inspection report for the viperwire lot number have 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 event could not be determined.Bench testing has shown that the driveshaft tip bushing can be fractured at the weld site if spun over or into a kink or bend in the guidewire.Bench testing has also shown that spinning a driveshaft with no tip bushing through a bend in the guidewire can result in severe wear and eventual fracture of the guidewire.(b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 1225 old hwy 8; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 4666752
• MDR Text Key: 5728508
• Report Number: 3004742232-2015-00019
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• 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: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 119211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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): Other
• Patient Age: 70 YR
• Patient Weight: 64