MAUDE Adverse Event Report: Oscor Inc. SafeSheath® II; INTRODUCER, CATHETER

Model Number	SS9
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction

• Brand Name: SafeSheath® II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): Oscor Inc.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): Oscor Inc.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: mohit malkani ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; +1(727)937-2511
• MDR Report Key: 50430788
• Report Number: 1035166-2026-00069
• Device Sequence Number: 10422981
• Product Code: DYB
• UDI-Device Identifier: 30891492002259
• UDI-Public: 30891492002259
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: SS9
• Device Catalogue Number: SS9
• Device Lot Number: S10445125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown