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

Model Number DBP-125MICRO145

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

Device analysis: (b)(6) center risk management did not release the oad to csi.However, csi was allowed to visit the facility and perform a visual evaluation.Csi was not allowed to touch the device, but were allowed to take photos.Any manipulation of the device or components had to be approved and performed at (b)(6).Visual analysis of the oad was performed at (b)(6) center on (b)(6) 2016.The oad had a guide wire engaged in the handle with the brake locked.The control knob was fully forward.The distal strain relief was missing.The saline sheath and driveshaft were both kinked on the distal side of the glue plug.The driveshaft was fractured approximately 10cm proximal to the distal end of the saline sheath with the control knob forward.The distal end of the guide wire was approximately 5cm distal to the driveshaft fracture.It could not be determined whether or not the guide wire had been cut or had fractured.The distal segment of the driveshaft was not available for analysis and location of the segment was unknown.It was estimated that approximately 25cm of the distal driveshaft was missing.The saline line was connected to the oad and did not exhibit any damage.The guide wire hypotube support was connected to the motor assembly and the side securing clips were observed to be extending through the hypotube support slots as intended.The cable retainers remained attached to the bottom shell.When the brake was lifted and the guide wire was moved through the handle, it was observed that the driveshaft moved along with the guide wire.This is an indication that the oad driveshaft was stuck on the guide wire, however the etiology could not be conclusively determined.The control knob was able to be traversed without issue.While csi was on site at (b)(6) center, the physician shared images that showed the distal segment of the driveshaft after it was removed from the vessel during the procedure.The crown and tip bushing remained intact on the driveshaft.The proximal edge of the crown was covered in tissue.The tissue appeared to be wrapped circumferentially around the crown and driveshaft.The driveshaft section proximal to the crown was observed to be elongated.At the conclusion of the failure analysis investigation, the root cause of the device becoming stuck and subsequent surgical removal could not be determined.Csi was unable to perform a full failure analysis and was limited to visual inspection only.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).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, the device got stuck in the patient and required surgical removal.The target lesion was located in the dorsalis pedis (dp) artery.During treatment with a csi orbital atherectomy device (oad), the device stopped working.When the physician attempted to restart the oad, it would not spin.The physician then attempted to remove the oad out of the patient, but was unsuccessful.Subsequently, a surgical cutdown was performed in order to remove the oad.It was further discovered that the dorsalis pedis artery and anterior tibial artery had torn.At this point, an amputation of the patient's leg was performed.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL 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: 5520227
• MDR Text Key: 40989553
• Report Number: 3004742232-2016-00017
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)161130(10)145847
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• 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: 03/21/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 145847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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): Hospitalization; Required Intervention; Disability