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

Model Number DBEC-125

Device Problem No Flow (2991)

Patient Problem Chest Pain (1776)

Event Date 04/23/2015

Event Type  Injury  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a no-flow event was noted in the left anterior descending (lad) artery.The target lesion was 60mm in length and was located in the lad artery.The physician used a 6fr guide catheter, whisper support guidewire and emerge guidewire to access the lesion.The whisper guidewire was removed and exchanged for a csi coronary viperwire guidewire.A csi coronary orbital atherectomy device (oad) was then loaded onto the guidewire.The physician completed six runs at low speed ranging from 15 to 25 seconds each.The patient started complaining of chest pain and an angiogram revealed no flow in the lad artery.The physician removed the oad and then attempted to exchange the viperwire using an over-the-wire balloon and multiple other guidewires, but was unsuccessful.The physician advanced an emerge balloon over the viperwire into the lad and performed multiple balloon angioplasty inflations in an attempt to resolve the no flow event.Balloon angioplasty restored some flow, but slow flow was still noted.Post-angioplasty, the physician again attempted to exchange the viperwire and lost wire access while doing so.The physician then re-wired the vessel with a new guidewire and placed two overlapping stents resolving the no flow/slow flow event.The patient status remained stable throughout the procedure.

Manufacturer Narrative

Device analysis: the oad was returned with the original saline line and emerge balloon catheter with viperwire guidewire still engaged.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.Examination in the area of the adhered tissue did not reveal any damage that would have contributed to the tissue accumulation.The crown dimensions and location on the driveshaft were measured and met the drawing specification.Examination of the returned saline line did not reveal any damage that would have contributed to the reported event.The initial visual examination of the exposed sections of the guidewire engaged in the balloon catheter did not reveal any damage that would have contributed to the difficulties experienced during the procedure.Further examination of the guidewire spring tip revealed adhered biological material on the proximal solder bond site.Examination in this area did not reveal any damage that would have contributed to the tissue accumulation.The spring tip and proximal adhesive bond remained intact and undamaged.Examination of the returned balloon catheter revealed that the guidewire was seized within the inner catheter lumen.The balloon catheter seized up on the grind transition area of the guidewire.The inner shaft material of the balloon exhibited axial compression damage proximal to the balloon's marker band.The damage can be attributed to the seized guidewire having been manipulated during or after the procedure.The guidewire was removed from the balloon catheter with some resistance.Examination of the remaining section of the guidewire did not reveal any damage that would have contributed to the wire locking up within the balloon catheter.The balloon catheter was inflated to 16 atmospheres and did not exhibit any damage that would have contributed to the guidewire to seize up within the device.The guidewire was measured and met its dimensional specifications.An in-house 0.012" test wire was loaded through the oad 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.Sufficient fluid flow was observed emitting from the handle assembly/saline sheath with the control knob in the full backward position and when the control knob is in the full forward position.The device and components functioned as intended with no abnormalities observed.At the conclusion of the failure analysis investigation the root cause of the no flow event could not be determined.Analysis revealed that the returned guidewire was seized up within the returned balloon catheter, but removal difficulties were noted after the no flow event had occurred.The driveshaft and guidewire exhibited adhered biological material, but the device and wire were within specification and performed as intended during testing.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.The material inspection report for the viperwire lot number was not reviewed as the lot number is unknown.(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 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: 4784420
• MDR Text Key: 5801065
• Report Number: 3004742232-2015-00031
• 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: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 123810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 65