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

Model Number	C408507
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 6f engage introducer sheath was received for evaluation.The sheath had been stretched and torn, and the sheath tube had detached from the hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath detachment is consistent with damage during use.
Event or Problem Description
While removing the device from the right radial artery, the hub of the sheath detached.The sheath was pulled from the patient's anatomy without any intervention.The procedure was completed with manual compression and a hemo band.There were no adverse patient consequences.

• Brand Name: ENGAGE INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9382940
• Report Number: 3005334138-2019-00605
• Device Sequence Number: 19433622
• Product Code: DYB
• UDI-Device Identifier: 05414734030465
• UDI-Public: 05414734030465
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: 04/30/2022
• Device Model Number: C408507
• Device Catalogue Number: C408507
• Device Lot Number: 6945846
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR