MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 81 CM LENGTH, 8F; INTRODUCER, CATHETER

Model Number	407450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/26/2020
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.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 3008452825-2020-00549.During a pulmonary vein isolation ablation procedure, access was made via the femoral vein and catheters were placed into the right atrium.A double transseptal access was performed to access the left atrium.Mapping of the left atrium was started with a non-abbott mapping catheter, but when attempting to map with the ablation catheter it was noted that the angle of the transseptal sites were not workable so another transseptal access was obtained.After the new transseptal puncture was performed with the abbott needle and introducer, the patient became hypotensive.Heparin was stopped, adrenaline was given, and cpr was performed.Cardiac echography and trans-esophageal echocardiogram showed no cardiac tamponade.The patient was stabilized and transfer to icu for monitoring.There were no performance issues with any abbott device.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 81 CM LENGTH, 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10676741
• Report Number: 3005334138-2020-00497
• Device Sequence Number: 3449976
• Product Code: DYB
• UDI-Device Identifier: 05414734205740
• UDI-Public: 05414734205740
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/14/2020

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: 10/31/2021
• Device Model Number: 407450
• Device Catalogue Number: 407450
• Device Lot Number: 6750712
• 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: 09/15/2020
• Initial Report FDA Received Date: 10/14/2020
• 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: BRK TRANSSEPTAL NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention