MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER

Model Number	C407699
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the portico procedure, the valve of the ultimum ev hemostasis introducer was leaking blood.The portico valve was implanted without any complications and the procedure was completed without using another ultimum ev hemostasis introducer.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
The reported event of a leak could not be confirmed.The sheath passed pressure and aspiration leak testing with no anomalies observed.However, microscopic inspection revealed tearing on the proximal face of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.The cause of the torn seal is consistent with damage during use.

• Brand Name: ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7996787
• Report Number: 3005334138-2018-00383
• Device Sequence Number: 1386675
• Product Code: DYB
• UDI-Device Identifier: 05415067014382
• UDI-Public: 05415067014382
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K140327
• 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): 02/07/2019

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: 02/29/2020
• Device Model Number: C407699
• Device Catalogue Number: C407698
• Device Lot Number: 6381038
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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