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

Model Number	406804
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, while inserting dilator into introducer, dilator had punctured the introducer at the sheath tip.A new device was used to continue the procedure with no adverse patient consequences.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath and dilator were received for evaluation.The sheath tubing had been stretched and protruded in three locations within the manufactured curve.No punctures were noted.The shapes of the protruded material were 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 remains unknown.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• 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: 14475852
• Report Number: 3005334138-2022-00337
• Device Sequence Number: 17327229
• Product Code: DYB
• UDI-Device Identifier: 05414734203302
• UDI-Public: 05414734203302
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 08/31/2022
• Device Model Number: 406804
• Device Catalogue Number: 406804
• Device Lot Number: 7167520
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2019
• 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