MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7 F; INTRODUCER, CATHETER

Model Number 406702

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/30/2019

Event Type  Injury  

Event Description

Manufacturer related ref: 3005334138-2019-00511.During the procedure, the sheath broke inside the femoral vein.A vascular surgeon was able to remove the sheath.A second sheath was used and the device kinked and formed in the device.

Manufacturer Narrative

One fast-cath hemostasis introducer was returned to the manufacturer for analysis.The reported event of the reported event of a broken sheath was confirmed.The sheath had been torn at a bend 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 bend and tear is consistent with damage during use.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9086474
• MDR Text Key: 160324670
• Report Number: 3005334138-2019-00512
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734216951
• UDI-Public: 05414734216951
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K894343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 406702
• Device Catalogue Number: 406702
• Device Lot Number: 6746108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• 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
• Patient Outcome(s): Other; Required Intervention