MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. WIRION EMBOLIC PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE

Model Number	WRN-D6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The filter was received at csi for analysis.The filter was returned with a torn filter sac.The filter was able to be retrieved into the retrieval catheter during analysis.Per reported event details: "the physician pulled on the device and the filter broke in half." pulling the filter forcefully through the sheath likely contributed to the torn sac, however this could not be confirmed and the root cause of the filter damage remains unknown.The instructions for use for the wirion eps warns "always advance or retract the catheter slowly under fluoroscopic imaging.If resistance is felt and/or observed, determine the cause and take any necessary remedial action." at the conclusion of the device analysis investigation, the report that the filter broke in half was confirmed, however the report that the filter was difficult to retrieve could not be confirmed as the filter was able to be retrieved into the catheter during analysis.The material inspection report for this device 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 prior to distribution.Csi id: (b)(4).
Event or Problem Description
During retrieval of the wirion embolic protection system filter, it would not fully capture inside of the retrieval catheter, and therefore would not come out of the 6fr sheath.The physician pulled on the device and the filter broke in half.Popliteal access was obtained and the filter fragment was snared from below.The procedure was complete and angiography showed normal flow.The patient was discharged.

• Brand Name: WIRION EMBOLIC PROTECTION SYSTEM
• Common Device Name: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 12301188
• Report Number: 3004742232-2021-00284
• Device Sequence Number: 3612137
• Product Code: NTE
• UDI-Device Identifier: 10850000491882
• UDI-Public: (01)10850000491882(17)230223(10)0000079994
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: WRN-D6
• Device Catalogue Number: 7-10078-01
• Device Lot Number: 0000079994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention