MAUDE Adverse Event Report: OSCOR, INC. DESTINO TWIST STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	DST0704509
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
We opened an oscor destino twist, dst0704509, they stated that as they went to use it, it was frayed on the end.Defect was noted immediately prior to use; was not used on the patient.An identical sheath was obtained; had no defects and was successfully used on the patient.

• Brand Name: DESTINO TWIST STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR, INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 8128237
• Report Number: 8128237
• Device Sequence Number: 1487316
• Product Code: DYB
• UDI-Device Identifier: 00885672004125
• UDI-Public: (01)00885672004125(17)211001(10)C8-15680
• 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): 11/13/2018
• Report Date (Section F): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DST0704509
• Device Catalogue Number: DST0704509
• Device Lot Number: C8-15680
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65
• Date Report Sent to FDA: 11/21/2018