MAUDE Adverse Event Report: FREUDENBERG MEDICAL, LLC STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL

Model Number	SS085075M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolus (1830)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician confirmed the stroke was not related to the introducer sheath and there are no alleged deficiencies regarding the device.The results of the investigation are inconclusive as the device was not returned for analysis.A review of the device history record was not possible as the lot number was not reported.Per the ifu, embolism and stroke are associated risks with the use of this device.The ifu contains contraindications against use of this device for those with recent cerebral vascular accidents or embolic events.
Event or Problem Description
It was reported that while using the catheter introducer sheath the patient had a stroke while going transseptal.The physician was able to confirm that the stroke was not related to the introducer sheath and there are no alleged deficiencies regarding the device.

• Brand Name: STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL
• Common Device Name: STEERABLE INTRODUCER SHEATH
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 2301 centennial blvd; jeffersonville IN 47130 8975
• MDR Report Key: 9607957
• Report Number: 1000121130-2020-00001
• Device Sequence Number: 19517738
• Product Code: DYB
• UDI-Device Identifier: 00850004312025
• UDI-Public: 00850004312025
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K191190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: SS085075M
• Device Catalogue Number: PN1008533-002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/20/2020
• 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: Life Threatening; Required Intervention