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

Model Number SS085075M

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

Patient Problem Embolus (1830)

Event Date 12/20/2019

Event Type  Injury  

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 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
• Type of Device: STEERABLE INTRODUCER SHEATH
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 2301 centennial blvd; jeffersonville IN 47130 8975
• Manufacturer (Section G): FREUDENBERG MEDICAL, LLC; 2301 centennial blvd; jeffersonville IN 47130 8975
• Manufacturer Contact: emily logsdon ; 2301 centennial blvd; jeffersonville, IN 47130-8975 ; 8122804814
• MDR Report Key: 9607957
• MDR Text Key: 176235989
• Report Number: 1000121130-2020-00001
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00850004312025
• UDI-Public: 00850004312025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SS085075M
• Device Catalogue Number: PN1008533-002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention