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

Model Number PRD-SC30-MICRO

Device Problem Entrapment of Device (1212)

Patient Problem Perforation of Vessels (2135)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device analysis results: the oad was received at csi for analysis.No damage was observed on the handle assembly.There was some adhered material observed on the driveshaft and crown.Examination of the areas of adhered material did not reveal any damage that would have contributed to the accumulations.The morphology and exact root cause of the accumulation is unknown.The biological material accumulation likely contributed to the device becoming stuck on the guide wire; however, the root cause remains undetermined.The guidewire was also received and was engaged in the oad.No damage was observed on the guide wire.At the conclusion of the device analysis investigation, the report that the oad became stuck on the wire was confirmed.However, the reported perforation could not be confirmed through 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.Csi id: (b)(4).

Event Description

A stealth peripheral orbital atherectomy device (oad) was used to treat a chronic total occlusion in the anterior tibial artery.Access was obtained in the right common femoral artery, and the approach was contralateral.One treatment was performed on low speed, and the oad became stuck on the guide wire.The oad and wire were removed, and a perforation occurred.The perforation was resolved with angioplasty.The patient was stable following the procedure.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 11304152
• MDR Text Key: 231126556
• Report Number: 3004742232-2021-00038
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)220930(10)346108
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 346108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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: 82 YR
• Patient Weight: 64