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

Model Number	406180
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation procedure, the body of the introducer was torn.When removing the introducer, the body was torn 15 cm proximal to the tip and the proximal part of the sheath appeared stretched in a longitudinal direction.A portion of the sheath was removed and an x-ray confirmed no sheath material remained in the patient.No resistance was noted when removing, inserting, and manipulating the catheter into the sheath.The procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
One fast-cath hemostasis introducer was returned for analysis.The sheath had been stretched and torn.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the stretched and torn sheath is consistent with damage during use.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8392053
• Report Number: 3005334138-2019-00115
• Device Sequence Number: 13820939
• Product Code: DYB
• UDI-Device Identifier: 05414734014410
• UDI-Public: 05414734014410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 07/31/2021
• Device Model Number: 406180
• Device Catalogue Number: 406180
• Device Lot Number: 6600858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1