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

Model Number 406153

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During the procedure, the introducer was inserted into the patient but resistance was noted.The device was withdrawn and the device was noted to be kinked.The device was replaced to resolve the issue with no adverse patient consequences.Due to having to exchange the introducer, a second femoral access site had to be created.

Manufacturer Narrative

One 6.5f fast-cath introducer sheath was received for evaluation.The sheath tubing had been kinked, stretched and perforated in one location, proximal to the distal tip.The shape of the perforated material was consistent with the shape of the dilator distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The damage to the sheath is consistent with forcible contact between the dilator and the inner diameter of the sheath during dilator insertion.The cause of the forcible contact and reported patient insertion difficulty remains unknown.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• 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: 13479660
• MDR Text Key: 285805625
• Report Number: 3005334138-2022-00080
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734014274
• UDI-Public: 05414734014274
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: K914090
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 406153
• Device Catalogue Number: 406153
• Device Lot Number: 7751557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• 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