MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED INTRODUCER; INTRODUCER, CATHETER

Model Number	406853
Medical Device Problem Codes	Fracture (1260); Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
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 a pulmonary vein isolation procedure, the device was placed into the patient and after removing the dilator, the soft tip of the sheath was noted to be flared.Additionally, the shaft of the introducer fractured just above the hub.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event of sheath fracture and soft gray tip damage was confirmed.The sheath had been torn just distal to the hemostasis hub; the sheath tubing remained attached.The sheath soft gray tip was flared.The cause of the sheath fracture and soft gray tip damage is consistent with damage during use.

• Brand Name: SWARTZ BRAIDED INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11143042
• Report Number: 3005334138-2021-00006
• Device Sequence Number: 2231480
• Product Code: DYB
• UDI-Device Identifier: 05414734202985
• UDI-Public: 05414734202985
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 06/30/2023
• Device Model Number: 406853
• Device Catalogue Number: 406853
• Device Lot Number: 7595064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1