MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿; INTRODUCER, CATHETER

Model Number	406844
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the ablation portion of an atrioventricular nodal reentrant tachycardia (avnrt) supraventricular tachycardia (svt) procedure, insertion difficulties with the sheath resulted in a procedural delay.It was noted that the ablation catheter was not reaching the set power limit on the ampere.The catheter was removed from the patient, and it was observed that the catheter was not irrigating despite attempting to fast flush at 60 ml/min.The introducer and the ablation catheter were exchanged to complete the procedure with no adverse consequences to the patient.When the guidewire was removed during the device exchange it was noted to be bent and kinked.After discussing with the team what we saw, it seems that the sheath damaged both the wire and the ablation catheter when they were advanced into the patient through this sheath.No resistance was noted while inserting the catheter through the sheath but there was resistance when removing it from the patient.When the introducer was exchanged, the new introducer was advanced through the existing access site.When the sheath was removed, no physical damage was observed.
Additional Manufacturer Narrative
One 8f fast-cath introducer sheath and dilator were received for evaluation.The damage to the guidewire could not be confirmed as it was not returned for analysis.The sheath hemostasis cap inside diameter measurement was within specifications and no anomalies were noted when the returned dilator was inserted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Flexability instructions for use (ifu) states, ¿an 8.5f minimum introducer sheath may be used to aid in insertion.¿ the cause of the reported removal difficulty is consistent with not following the instructions for use.The cause of the reported guidewire damage remains unknown.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿
• Common Device Name: 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: 18624071
• Report Number: 3005334138-2024-00023
• Device Sequence Number: 7668157
• Product Code: DYB
• UDI-Device Identifier: 05414734202930
• UDI-Public: 05414734202930
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 406844
• Device Lot Number: 8932564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown