MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406123
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The fast-cath hemostasis introducer was bent during insertion in the femoral vein.An ablation catheter was inserted into the sheath and the catheter punctured through the sheath wall.The sheath was removed and procedure was completed by performing an additional femoral puncture and inserting an slo.There were no consequences to the patient.
Additional Manufacturer Narrative
One fast-cath hemostasis introducer was returned for analysis.The sheath had been bent in multiple locations and was twisted and torn.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend, twist, and tear is consistent with damage during use.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8287870
• Report Number: 3005334138-2019-00041
• Device Sequence Number: 2575143
• Product Code: DYB
• UDI-Device Identifier: 05414734014038
• UDI-Public: 05414734014038
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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 Expiration Date: 06/30/2021
• Device Model Number: 406123
• Device Catalogue Number: 406123
• Device Lot Number: 6559337
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 100