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

Model Number	C408536
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The engage tr introducer was used in procedure and fractured near the proximal base of the device when attempting to insert into the patient.It is unknown how the procedure was completed.No additional information is expected.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.
Additional Manufacturer Narrative
Product evaluation: the reported event of hemostasis hub detachment was confirmed.Visual inspection revealed that the hemostasis hub had been detached and separated from the sheath tubing; a crease parallel with the sheath was noted at the proximal end of the sheath.Additional investigation revealed the header was formed properly and had elongated prior to separating.The header condition met vision system specifications post tensile testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the detached hemostasis hub remains unknown.The engage introducer sheath instruction for use (ifu) states to advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.

• Brand Name: ENGAGE TR INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7900183
• Report Number: 3005334138-2018-00327
• Device Sequence Number: 11150913
• Product Code: DYB
• UDI-Device Identifier: 05414734030403
• UDI-Public: 05414734030403
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093130
• 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): 12/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: C408536
• Device Catalogue Number: C408536
• Device Lot Number: 6450782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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: Hospitalization; Other; Required Intervention