MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407456
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes, along with investigation results will be provided in a subsequent submission. .
Event or Problem Description
During the procedure, the tip and center of the introducers were fractured.The fractures were segmented along the introducer shaft, and the material was being held together by the braided material.The introducers were replaced, and the procedure was completed with no adverse consequences to the patient.No additional access site was required during replacement.
Additional Manufacturer Narrative
The reported event of a device fracture was confirmed.The soft gray tip and sheath tubing had been fractured into pieces.In addition, inspection of the device identified degradation of shaft material.The damage is consistent with the product being stored outside of the shelf box and exposed to light.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The product instructions for use (ifu) artmt100093395 ver.A warns that product should be stored in a cool, dark, dry place.The cause of the degradation is consistent with not following the instructions for use.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2, 81 CM LENGTH, 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11013872
• Report Number: 3005334138-2020-00630
• Device Sequence Number: 2975304
• Product Code: DYB
• UDI-Device Identifier: 05414734205801
• UDI-Public: 05414734205801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 10/31/2021
• Device Model Number: 407456
• Device Catalogue Number: 407456
• Device Lot Number: 6741446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER