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

Model Number	C408508
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The side port of the introducer detached during the procedure.The sheath was removed and the pressure was held.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.However, information from the field stated that ¿the sheath had been left inside the patient for days.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported sideport detachment could not be conclusively determined.Per the engage instructions for use (ifu) states, after completing procedure, withdraw the sheath and discard.
Event or Problem Description
Approximately two weeks post procedure, the sideport detached from the sheath.An engage introducer was used on 23march2022 for insertion of a swan ganzinto through the internal jugular vein.The procedure was completed with no issues and the patient returned to their room with the sheath still in place.On 05april2022 the side port of the introducer detached.The sheath was removed and the pressure was held.There were no adverse consequences to the patient.

• Brand Name: ENGAGE 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: 14347219
• Report Number: 3005334138-2022-00321
• Device Sequence Number: 14769933
• Product Code: DYB
• UDI-Device Identifier: 05414734053013
• UDI-Public: 05414734053013
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 10/31/2024
• Device Model Number: C408508
• Device Catalogue Number: C408508
• Device Lot Number: 8179494
• Was Device Available for Evaluation?: No
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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