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

Model Number DBP-125SOLID145

Device Problems Entrapment of Device (1212); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Seizures (2063)

Event Date 09/23/2016

Event Type  Death  

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.The lot number was not recorded and could not be obtained.(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 caused additional unplanned intervention.The target lesion was very calcified and was located in the anterior tibial (at) artery.The physician advanced a csi viperwire guide wire across the lesion and loaded the oad onto it.The physician successfully treated the proximal segment of the lesion and then advanced the oad to the distal segment.While treating the distal segment, the device got stuck at a sharp takeoff in the at artery.The physician attempted to remove the oad for 90 minutes, but was unsuccessful.At some point, the femoral access site developed a large internal arterial tear.Manual pressure was applied in an attempt to stop the bleeding, but the patient's blood pressure declined.A blood transfusion was performed, but the patient had a seizure at this point and expired.It could not be determined exactly what caused the bleeding at the access site.The oad was not removed from the patient before the patient expired.Additional information has been requested, but none has yet been received.

• Brand Name: DIAMONDBACK 360 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: jacob mellem ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 6039522
• MDR Text Key: 57807463
• Report Number: 3004742232-2016-00119
• 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
• Report Date: 10/18/2016

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 Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/19/2016
• 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): Death