MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 F; INTRODUCER, CATHETER

Model Number 406701

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

During a pulmonary vein isolation procedure for atrial fibrillation, the sheath broke and detached during the z-suture and remained in the groin.The patient was transferred to vascular surgery where the detached portion was removed under fluoroscopy.Per the surgeon, there were no further consequences to the patient.

Manufacturer Narrative

One 6f fast-cath introducer sheath was received for evaluation.The sheath tubing had been torn and stretched into two sections; both sections were returned; the distal section had been kinked and twisted proximal to the distal tip.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, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6 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: 15074592
• MDR Text Key: 299371698
• Report Number: 3005334138-2022-00425
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734216944
• UDI-Public: 05414734216944
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 406701
• Device Catalogue Number: 406701
• Device Lot Number: 8446368
• 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: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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