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

Model Number	DST0704509
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
One of the supplies oscor twist shearable sheath malfunctioned.The dilator wouldn't advance into the sheath, it was stuck.

• 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: 14694937
• Report Number: 14694937
• Device Sequence Number: 5327422
• Product Code: DYB
• UDI-Device Identifier: 00885672004125
• UDI-Public: (01)00885672004125(17)241101(10)DP14485
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2022
• Report Date (Section F): 05/18/2022

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: DST0704509
• Device Catalogue Number: DST0704509
• Device Lot Number: DP14485
• 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: 06/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 05/18/2022