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

Model Number PRD-SC30-MICRO

Device Problem Entrapment of Device (1212)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id#: (b)(4).

Event Description

During a procedure, the stealth peripheral orbital atherectomy device (oad) was used to treat a small, tight lesion.The oad became stuck in the lesion and the oad was stuck on the wire.The oad and guide wire were removed together from patient and wire access was lost.Contained extravasation was observed and was treated with balloon tamponade.The vessel shut down, however, the patient still had two other vessels open.The physician declined to provide additional event details.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h3, h6, h10.The reported oad and guide wire were received, engaged, for analysis.The guide wire was seized within the driveshaft in the crown and tip bushing area.The proximal guide wire spring tip coil was damaged and deformed; however, no fractures were observed.Adhered biological material was observed on the proximal solder bond of the guide wire and on the oad driveshaft and crown edges.Examination of the areas of adhered material did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulations were unknown.The guide wire was removed from the oad.Examination of the guide wire did not reveal any rotation or surface wear.A guide wire was passed through the oad with no resistance.The oad was tested, spun at all speeds, and functioned as intended.At the conclusion of the device analysis, the reported event of the oad being stuck on the wire was confirmed, however, the reported perforation and oad being stuck in the lesion were unable to be conclusively confirmed.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.Results code: 4247: suggested code is biological material present on device csi id# (b)(4).

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10197159
• MDR Text Key: 196581053
• Report Number: 3004742232-2020-00182
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)211130(10)299647
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 299647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR