MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH® II; INTRODUCER, CATHETER

Model Number	SS6
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medical doctor (md) went to crack the wings of the peel-away safesheath, the rubber grommet on the inside of the sheath did not split as designed.The rubber grommet then stayed on the lead and md had to pull it apart.This then leaves a chance of particles falling in the pocket.

• Brand Name: SAFESHEATH® II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 4875 palm harbor blvd; palm harbor FL 34683
• MDR Report Key: 22043672
• Report Number: 22043672
• Device Sequence Number: 18396634
• Product Code: DYB
• UDI-Device Identifier: 00891492002210
• UDI-Public: (01)00891492002210(17)290501(10)S9088456
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2025
• Report Date (Section F): 05/08/2025

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: SS6
• Device Catalogue Number: SS6
• Device Lot Number: S9088456
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Date Report Sent to FDA: 05/08/2025