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

Model Number	SS085075M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter tip crimping on itself upon femoral access insertion.

• Brand Name: STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 2301 centennial blvd.; jeffersonville IN 47130
• MDR Report Key: 12480522
• Report Number: 12480522
• Device Sequence Number: 3848385
• Product Code: DYB
• UDI-Device Identifier: 00850004312025
• UDI-Public: (01)00850004312025(17)220405(10)0000177408
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/13/2021
• Report Date (Section F): 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SS085075M
• Device Catalogue Number: PN1008533-002
• Device Lot Number: 0000177408
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 09/13/2021