MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2, 63 CM LENGTH, 8F; INTRODUCER, CATHETER

Model Number	407441
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a successful procedure, difficulty was noted when withdrawing the introducer.The tip of the introducer was then noted to partially separate when removing the introducer from the patient.A small incision was made at the access site and the physician was able to retrieve the introducer tip with a hemostat so the introducer could be removed from the patient without the tip fully detaching.There were no adverse consequences to the patient outside of an extra suture needed at the access site.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 8f swartz braided introducer sheath was received for evaluation.The soft gray tip and sheath tubing had been fractured into pieces and the tip marker was detached; the distal tip material and tip marker were not returned.Inspection of the device identified degradation of shaft material.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the degradation remains unknown.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2, 63 CM LENGTH, 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11820511
• Report Number: 3005334138-2021-00317
• Device Sequence Number: 19770147
• Product Code: DYB
• UDI-Device Identifier: 05414734205658
• UDI-Public: (01)05414734205658(10)6920183(17)220228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 407441
• Device Catalogue Number: 407441
• Device Lot Number: 6920183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention