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

Model Number DBEC-125

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Foreign Body In Patient (2687)

Event Date 12/01/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The device and wire are being retained by the facility for internal investigation.It is anticipated that the facility will return the device and wire to csi for analysis, but they have not yet been received.(b)(4).

Event Description

It was reported that during a coronary orbital atherectomy procedure, a csi coronary orbital atherectomy device (oad) got stuck in the patient and required surgical removal.The target lesion was 15mm in length, 85% stenotic and was located in the right coronary artery (rca).The physician accessed the lesion using an 8fr introducer sheath, 8fr guide catheter and a sion blue 0.014" guide wire.The sion guide wire was exchanged for a csi viperwire guide wire and the oad was loaded onto it.The physician performed three runs at low speed in the lesion, and a fourth run at low speed when retracting the oad proximally.During the fourth run, the oad stopped spinning and became stuck in the patient.The physician cut the driveshaft advanced a catheter over it, but when he pulled the driveshaft, a portion of the driveshaft and guide wire spring tip broke off.After four hours of unsuccessful removal attempts, the patient was taken to the operating room for surgical removal of the oad and guide wire.During surgery, the physician successfully removed the proximal portion of the driveshaft and proximal portion of the csi guide wire.A distal section of the driveshaft with attached crown, and guide wire spring tip, were left in the patient.The patient status was stable throughout the intervention, but the patient expired on (b)(6) 2015.

Manufacturer Narrative

Device analysis: the oad and distal driveshaft section were returned with the original guide wire spring tip lodged within the driveshaft tip bushing section.The initial visual examination of the driveshaft section revealed that it had been destructively cut 12.2cm proximal to the tip bushing.Further examination of the driveshaft section revealed that the crown and driveshaft tip bushing remained intact and undamaged.Biological material was observed on the crown, driveshaft and within the driveshaft filars.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft revealed that the driveshaft had been destructively cut just distal to the strain relief.Destructive analysis revealed that the driveshaft was severely stretched at the lap weld extending distally.Further examination revealed that the proximal adhesive bond of the spring tip was lodged within the tip bushing.The spring tip, driveshaft and crown exhibited adhered biological material.Resistance was met when removing the spring tip from the tip bushing.Examination of the spring tip and proximal adhesive bond revealed that the spring tip core wire was not present within the spring tip coil or driveshaft section.Only the spring tip coil portion of the guide wire was returned.The distal spring tip solder bond remained intact and undamaged.The spring tip coils were stretched out to expose any remaining core wire and distal solder bond site.A short segment of core wire was present and exhibited twisting damage that is consistent with an oad tip bushing spinning over the guide wire spring tip.The returned spring tip was sent for scanning electron microscope (sem) analysis.Sem analysis identified axial marks on the proximal adhesive bond area.Due to the damage at the lap weld, an in-house.012" test guide wire was back loaded (rather than through the proximal end) through the oad handle assembly to allow for functional testing.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 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.At the conclusion of the failure analysis investigation, the root cause of the device becoming stuck in the patient and requiring surgical removal could not be determined.Biological material was observed on the driveshaft and crown, but it could not be conclusively determined whether or not that was the etiology of the event.(b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY 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: 5331894
• MDR Text Key: 34572315
• Report Number: 3004742232-2015-00093
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)170630(10)131140
• 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: 12/21/2015

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: 06/30/2017
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 131140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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): Death; Hospitalization; Required Intervention