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

Model Number DBEC-125

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Perforation (2001); Stenosis (2263); Complaint, Ill-Defined (2331)

Event Date 02/09/2015

Event Type  Death  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a perforation occurred while using a csi orbital atherectomy device (oad).The target lesion was 95% stenotic and was located in the left anterior descending (lad) artery.The physician used a run through crossing wire and quickcross catheter to access the lesion.The physician exchanged the crossing wire for a csi coronary viperwire guidewire and loaded the csi oad onto the guidewire.The physician completed two runs at low speed and two runs at high speed.Post-atherectomy angiography revealed a perforation at the site of treatment.The physician then placed two covered stents, but the patient status started to decline.A balloon pump and temporary pacemaker were placed in the patient, but the patient coded.Cardiopulmonary resuscitation (cpr) was performed to revive the patient.The patient was transferred to the intensive care unit (icu) post-procedure.Three requests for additional information have been made, but none has yet been received.

Event Description

The patient expired four (4) days post-case and the physician stated it was related to the perforation that occurred during the case.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device analysis: the oad was returned with the original guidewire.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft did not reveal any damage that would have contributed to the reported event.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.The crown specifications and crown location on the driveshaft were measured and met the drawing specifications.The initial visual and tactile examination of the guidewire revealed numerous kinks along the shaft.It could not be determined if the kinks were present during the case or occurred as a result of handling or manipulation after the case.Further examination revealed that the spring tip and proximal adhesive bond remained intact and undamaged.An in-house 0.012" test wire was loaded through the device with no resistance.When tested, the device spun at low 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 observed.At the conclusion of the failure analysis investigation, the root cause of the perforation could not be determined.Biological material was observed on the driveshaft and crown, but the exact morphology of the material was not determined.The case details did not mention any device malfunction that would have caused the biological material accumulation.The device was within specification and performed as intended when tested.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).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 4549403
• MDR Text Key: 5524182
• Report Number: 3004742232-2015-00012
• 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,Followup
• Report Date: 02/23/2015

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: 03/31/2016
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 97650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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): Death; Required Intervention