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 Problem No Code Available (3191)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

It is unknown whether or not the device will be returned to csi.A supplemental report will be sent if the device is received for analysis.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a csi orbital atherectomy device (oad) got stuck in the patient and required surgical removal.The target lesion was moderately calcified, 3cm in length and 100% stenotic.It originated in the distal anterior tibial (at) artery and extended into the lateral plantar arch.The physician advanced a csi viperwire guide wire across the lesion and loaded the oad onto it.The physician performed one run at low speed across the lesion, but when retracting the oad proximally, the device got stuck and turned off.After multiple unsuccessful removal attempts, the patient was taken to the operating room for surgical removal of the oad.A cutdown of the dorsalis pedis (dp) artery was made and the oad was removed.The patient status remained stable throughout the procedure.Requests for additional information and device return have been made, but nothing has yet been received.It is unknown if csi will be able to obtain the oad for analysis.

Manufacturer Narrative

The device was not returned to csi for analysis.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).Not returned to csi.

Event Description

Facility medwatch received, which stated that, "per the surgeon, the guide wire got stuck in the patient's vessel likely due to calcification and the patient's anatomy and the curvature of the artery.It is unknown whether device malfunction was a contributing factor but it appears the device could not fucntion normally once the guide wire became lodged.".

• 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: 5656494
• MDR Text Key: 45224179
• Report Number: 3004742232-2016-00035
• Device Sequence Number: 1
• Product Code: MCW
• 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,Followup
• Report Date: 05/12/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 145812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 73 YR