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

Model Number	407845
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Further information was requested but not received.
Event or Problem Description
Related manufacturing ref: 3005334138-2019-00425, 3005334138-2019-00426.Following an atrial fibrillation procedure, the patient experienced a stroke.Following the procedure, the patient was observed in the hospital for 8 days and then discharged.A few days later, the patient presented to the hospital for a stroke.The patient was alert on (b)(6) 2019.Paralysis of one side of the body seemed to be regressing.There were no performance issues with any abbott devices.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.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 stroke remains unknown.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8854749
• Report Number: 3005334138-2019-00427
• Device Sequence Number: 16748350
• Product Code: DYB
• UDI-Device Identifier: 05414734011075
• UDI-Public: 05414734011075
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K001346
• 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): 08/13/2019

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: 12/31/2021
• Device Model Number: 407845
• Device Catalogue Number: 407845
• Device Lot Number: 6794912
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER; ULTIMUM HEMOSTASIS INTRODUCER; SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER; ULTIMUM HEMOSTASIS INTRODUCER
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 68 YR
• Patient Weight: 108