MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8F; INTRODUCER, CATHETER

Model Number	407360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
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 incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 3008452825-2019-00529, 3008452825-2019-00530, 3008452825-2019-00540, 3008452825-2019-00541.Following completion of the procedure, the patient showed signs of hemiplegia.Less than 15 minutes later the patient had no further symptoms and magnetic resonance imaging (mri) was negative for a cerebrovascular accident (cva).No intervention was needed and the patient was discharged in stable condition.There were no performance issues with any abbott device during the procedure.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9309261
• Report Number: 3005334138-2019-00586
• Device Sequence Number: 2509324
• Product Code: DYB
• UDI-Device Identifier: 05414734205559
• UDI-Public: 05414734205559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052644
• 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
• Report Date (Section B): 11/12/2019

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: 05/31/2022
• Device Model Number: 407360
• Device Lot Number: 7064988
• 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: 10/21/2019
• Initial Report FDA Received Date: 11/12/2019
• 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: ADVISOR FL CATHETER; BRK TRANSSEPTAL NEEDLE; INQUIRY STEERABLE CATHETER; TACTICATH SE CATHETER
• Outcome Attributed to Adverse Event: Other