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

Model Number	406108
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the fast-cath hemostasis introducer fractured at the proximal end and remained lodged in the patient.A snare and sl0 sheath were used to remove the fractured portion of the introducer and the procedure was completed with no patient consequences.
Additional Manufacturer Narrative
The reported event of sheath fracture was confirmed.The results of the investigation concluded the hemostasis sheath had been fractured into two sections, consistent with the reported event.The fractured ends appeared cut and torn.The sheath had been split at the distal tip, kinked, and flattened.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the hemostasis sheath damage 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: 8121484
• Report Number: 3005334138-2018-00459
• Device Sequence Number: 13536713
• Product Code: DYB
• UDI-Device Identifier: 05414734013833
• UDI-Public: 05414734013833
• 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): 02/08/2019

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: 05/31/2021
• Device Model Number: 406108
• Device Catalogue Number: 406108
• Device Lot Number: 6494205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention