MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7.5 F; INTRODUCER, CATHETER

Model Number	406705
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, one image was submitted for evaluation.The image appears to show that the catheter was fractured distal to the hemostasis hub, consistent with the reported event.Visual inspection was based solely upon a review of the photographs received.The device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured introducer remains unknown.
Event or Problem Description
During an atrial fibrillation ablation procedure the distal portion of the sheath detached within the patient.The sheath detached at the hub and traveled into the patient's right atrium.A snare was used to retrieve the detached portion and fluoroscopy confirmed successful removal.The patient was stable.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7.5 F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7674064
• Report Number: 3005334138-2018-00194
• Device Sequence Number: 11151402
• Product Code: DYB
• UDI-Device Identifier: 05414734216982
• UDI-Public: 05414734216982
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K894343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 406705
• Device Catalogue Number: 406705
• Device Lot Number: 6297768
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/10/2018
• 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