MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number DBE-150

Device Problem Entrapment of Device (1212)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

A stealth peripheral orbital atherectomy device (oad) was used to treat a chronic total occlusion in the mid and proximal anterior tibial artery (at).During treatment, an audible increase in pitch was noted.The oad was stopped and an attempt was made to remove the device, however the crown was stuck in the vessel.Several attempts were required to remove the device via pulling, and an angiogram following removal showed a small perforation.Multiple balloon inflations were performed and heparin was administered over a 25-30 minute period to resolve the perforation.The tip of the oad appeared damaged following removal.The patient was discharged and was monitored over the following 72 hours.There were no additional complications reported.

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 10701575
• MDR Text Key: 212064739
• Report Number: 3004742232-2020-00324
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)220331(10)319814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 319814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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: 83 YR