MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407453

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, an additional access site was required to replace the device and the procedure continued without any consequences to the patient.

Manufacturer Narrative

One 8.5f swartz braided introducer sheath and dilator were received for evaluation.The guidewire assembly was also returned.The dilator distal tip had been split and one of the vacuum relief holes at the distal end of the sheath was stretched and bent.Functional testing confirmed contact between the dilator distal tip and the damaged vacuum relief hole, consistent with the reported dilator insertion difficulty.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1¿, 63 CM LENGTH, 8.5F
• 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: 14470446
• MDR Text Key: 292390828
• Report Number: 3005334138-2022-00335
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205771
• UDI-Public: 05414734205771
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K052644
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 407453
• Device Catalogue Number: 407453
• Device Lot Number: 8030635
• 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: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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