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 Codes	Foreign Body Embolism (4439); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, the hemostasis valve detached.The procedure was completed and upon removal of the sheath, it was noted that the hemostasis valve had detached from the tip.Fluoroscopy was performed, which revealed the hemostasis valve remained in the patient.The detached portion was removed using a forceps from the same side of the right inguinal region, but it did not reach, and the guidewire preceded from the contralateral side, and removal was successful with a snare.There were no consequences to the patient.The cause of the detachment was likely due to excessive torsional force applied to the sheath.
Additional Manufacturer Narrative
One 7.5f fast-cath introducer sheath was received for evaluation.Visual inspection revealed the sheath tubing had been torn, stretched and twisted into two sections; both sections were returned.The distal section had been kinked at 0.43¿, 2.16¿ and 2.81¿ proximal to the distal tip; the sheath tubing had been torn 4.11¿ proximal to the distal tip.The proximal section had been creased at 0.45¿ and had been torn at 1.18¿ distal to the distal end of the hemostasis hub; the proximal section remained attached to the hemostasis hub.No other visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath detachment is consistent with damage during use.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13928891
• Report Number: 3005334138-2022-00263
• Device Sequence Number: 6251747
• Product Code: DYB
• UDI-Device Identifier: 05414734216982
• UDI-Public: 05414734216982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 03/31/2022
• Device Model Number: 406705
• Device Catalogue Number: 406705
• Device Lot Number: 6935518
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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
• Patient Sex: Unknown