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

Model Number PRD-SC30-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Device analysis conclusion: the device and wire were received at csi for analysis.Visual examination did not reveal damage or abnormalities that would have contributed to the reported perforation.The driveshaft crown outer diameter was measured and met drawing specifications.The oad operated as intended during functional testing.The device data log did not reveal any issues that would have contributed to the reported complaint.There was some adhered biological material observed on the oad driveshaft, oad crown, and wire spring tip solder bond.The material prevented the returned wire from passing through the oad.Analysis did not identify any damage that may have contributed to the accumulating material.The morphology and exact root cause of the accumulation is unknown.The accumulated material may have contributed to the reported complaint, however this is not confirmed.The root cause of the reported perforation could not be confirmed through device analysis.When tested the device functioned as intended.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

Three treatments (one treatment on each speed) were administered with a stealth pluto orbital atherectomy device (oad) in the peroneal artery via right groin access and contralateral approach.The treatment speed seemed to slow during the final treatment, and the patient reported pain.The oad was turned off, and tissue was observed on the crown upon removal from the patient.Angiogram showed a perforation in the peroneal artery.No devices could be advanced over the wire through the perforated area despite multiple attempts.A blood pressure cuff was placed externally to control the perforation.The patient continued to complain of pain, but the patient was unsure whether the pain was in vivo or ex vivo (from the cuff).Protamine was administered to reverse heparin.Pain medications were also administered.The patient was alert following the procedure.

• Brand Name: STEALTH PERIPHERAL 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: 11327303
• MDR Text Key: 231980675
• Report Number: 3004742232-2021-00019
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)220831(10)340040
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 340040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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: 87 YR
• Patient Weight: 56