MAUDE Adverse Event Report: OSCOR, INC. ADELANTE MAGNUM; INTRODUCER, CATHETER

Model Number	ASM016030
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sheath was broken while exchanging out the sheath.This broke outside of the patient's body and did not negatively impact this patient.

• Brand Name: ADELANTE MAGNUM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR, INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 8334835
• Report Number: 8334835
• Device Sequence Number: 16473475
• Product Code: DYB
• UDI-Device Identifier: 00885672004736
• UDI-Public: (01)00885672004736(17)201201(10)C811865
• 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): 02/01/2019
• Report Date (Section F): 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASM016030
• Device Catalogue Number: ASM016030
• Device Lot Number: C811865
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/01/2019