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

Model Number PRD-SC30-200

Device Problem Obstruction of Flow (2423)

Patient Problem Embolism (1829)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported that during a peripheral orbital atherectomy procedure, distal embolization occurred after using a csi orbital atherectomy device (oad).The target lesion was 60mm in length, 100% stenotic and was located in the superficial femoral artery (sfa).The physician used a 6fr introducer sheath to access the lesion.The physician treated the lesion using the csi oad, but post-atherectomy there was distal embolization.The physician resolved the embolization by administering vasodilators.The patient status remained stable throughout the procedure.

Manufacturer Narrative

The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.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): discarded by facility.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 4418044
• MDR Text Key: 5416515
• Report Number: 3004742232-2015-00001
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: PRD-SC30-200
• Device Lot Number: 107348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2014
• 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: 50 YR
• Patient Weight: 64