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 Calcium Deposits/Calcification (1758); Chest Pain (1776); Perforation (2001)

Event Date 09/19/2014

Event Type  Injury  

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 calcified, 15mm in length and was located in the proximal circumflex artery.The physician used a 6fr introducer sheath and a 6fr fl4 guide catheter to access the lesion.A csi viperwire guidewire was advanced into the patient and across the lesion.The physician loaded the csi oad onto the guidewire and treated the lesion using one run at low speed and one run at high speed.After the run at high speed, the patient complained of chest pain.The oad was removed and a perforation was observed in the circumflex artery.The physician deployed a 2.75x18mm resolute stent across the perforation, but the perforation remained.The physician then inflated a 3.0x20 sprinter balloon multiple times for 20 minutes and was able to resolve the perforation.The patient status remained stable throughout the intervention.Three additional requests for information have been made, but none has yet been received.

Manufacturer Narrative

Device analysis the oad was returned without 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.No biological material was observed on the driveshaft or crown.The outside diameter (od) of the crown and crown location on the driveshaft were measured and met the drawing specifications.An in-house 0.012" test wire was loaded through the device without issue.When tested using an in-house saline pump, the device spun at low speed and at high speed with no abnormalities observed.Fluid was observed flowing out of the distal end of the saline sheath as intended.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.The device was within specification, performed as intended and no defect was found.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: 4170643
• MDR Text Key: 5093365
• Report Number: 3004742232-2014-00047
• 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: 10/08/2014

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: 07/31/2016
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 107173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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): Required Intervention