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

Device Problem Material Separation (1562)

Patient Problems Foreign Body Embolism (4439); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288031679
• Report Number: 3005334138-2022-00263
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734216982
• UDI-Public: 05414734216982
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1