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

Model Number	C408504
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Vascular Dissection (3160)
Type of Reportable Event	Serious Injury
Event or Problem Description
The engage introducer and the dilator were unable to be advanced on the guidewire despite the guidewire inserting without problem.When the guidewire was removed, it was kinked and the dilator was bent.A hematoma appeared in the venous lumen.Allegedly a venous dissection occurred.
Additional Manufacturer Narrative
The reported event of bent dilator and guidewire was confirmed.The results of the investigation concluded the dilator and guidewire had been bent, consistent with the reported event.Functional testing revealed the guidewire could be inserted through the hemostasis sheath/dilator assembly and exited the dilator distal tip without anomalies.Although the exact cause of the reported event remains unknown, the dilator and guidewire damage is consistent with the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the dilator and guidewire damage is consistent with damage during use.The engage introducer sheath instructions for use (ifu) states to advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.The engage introducer sheath instructions for use (ifu) states individual patient anatomy and physician technique may require procedural variations.The engage introducer sheath instructions for use (ifu) states damage to the valve assembly may occur if the inner catheter is withdrawn rapidly.The engage introducer instructions for use (ifu) states that upon removal of the hemostasis introducer, proper precautions should be taken to prevent bleeding.
Event or Problem Description
The engage introducer and the dilator were unable to be advanced on the guidewire despite the guidewire inserting without problem.When the guidewire was removed, it was kinked and the dilator was bent.A hematoma appeared in the venous lumen as well as a dissection.The device was withdrawn and compression was applied to the site.The procedure was stopped and the catheterization could not be performed.

• 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: 7801870
• Report Number: 3005334138-2018-00266
• Device Sequence Number: 1909205
• Product Code: DYB
• UDI-Device Identifier: 05414734052856
• UDI-Public: 05414734052856
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: C408504
• Device Catalogue Number: C408504
• Device Lot Number: 6463653
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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: Other