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

Model Number	DST0705509
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Per surgeon, this is a conformable "steerable" guiding sheath, however, the malfunction occurred when he attempted to steer it and it would not.Another device was opened and used successfully.The surgeon requests oscor request and obtain the device for analysis.

• 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: 9693347
• Report Number: 9693347
• Device Sequence Number: 2283785
• Product Code: DYB
• UDI-Device Identifier: 00885672004156
• UDI-Public: (01)00885672004156(17)220201(10)C8-16485
• 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): 01/24/2020
• Report Date (Section F): 01/24/2020

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: DST0705509
• Device Catalogue Number: DST0705509
• Device Lot Number: C8-16485
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 76
• Date Report Sent to FDA: 01/24/2020