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

Model Number	406137
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, resistance was noted and the sheath tube detached approximately 9cm proximal to the tip during insertion into right femoral vein.A balloon catheter was inserted into the sheath and inflated to remove the detached portion of the from the patient.A non abbott sheath was then inserted from the left femoral vein and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Correction: additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 3005334138.One 8.5f fast-cath introducer sheath was received for evaluation.A hydrophilic coated guidewire was also returned.The sheath tubing had been stretched and torn into two sections; both sections were returned.The distal section had been torn at 3.45¿ and had been perforated at 2.98¿ proximal to the distal tip.The distal section had multiple kinks at the distal tip through 0.50¿ proximal to the distal tip; the distal tip had been split.The proximal section of the sheath tubing had a protrusion at 0.68¿ and had been torn at 1.75¿ distal to the distal end of the hemostasis hub; the proximal section remained attached to the hemostasis hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing damage remains unknown.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14052518
• Report Number: 2182269-2022-00023
• Device Sequence Number: 4642009
• Product Code: DYB
• UDI-Device Identifier: 05414734012751
• UDI-Public: 05414734012751
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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 Expiration Date: 06/30/2024
• Device Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 8063098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown