MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969)
Date of Event	08/15/2018
Type of Reportable Event	Death
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: 9680001-2018-00129, 9680001-2019-00004, 2182269-2019-00004, 3005334138-2019-00020, 3005334138-2019-00021, 3005334138-2019-00023.Following an ablation procedure, the patient experienced a cerebral infarction and expired.During the procedure the patient was anticoagulated with heparin and the act monitoring was made in 30-minute intervals.After the procedure the patient did not wake up from anesthesia and subsequently expired.There were no performance issue with the device.Further information has been requested regarding the cva.
Event or Problem Description
Following an ablation procedure, the patient experienced a myocardial infarction and expired.During the procedure the patient was anticoagulated with eparine and the act monitoring was made in 30-minute intervals.After the procedure, the patient did not wake up from anesthesia and heart enzymes and heart catheterization confirmed the myocardial infarction.The patient subsequently expired.There were no performance issues with the device.No further information is available at this time.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8237255
• Report Number: 3005334138-2019-00022
• Device Sequence Number: 216702
• Product Code: DYB
• UDI-Device Identifier: 05414734014052
• UDI-Public: 05414734014052
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K914090
• 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): 01/14/2019

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: 04/30/2020
• Device Model Number: 406124
• Device Catalogue Number: 406124
• Device Lot Number: 5987781
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/14/2019
• 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: FAST-CATH INTRODUCER X 2; LIVEWIRE CATHETER; SWARTZ BRAIDED INTRODUCER; TACTICATH QUARTZ CATHETER X 2
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR