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

Model Number 406124

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969)

Event Date 08/15/2018

Event Type  Death  

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 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 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8237255
• MDR Text Key: 132758453
• Report Number: 3005334138-2019-00022
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734014052
• UDI-Public: 05414734014052
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K914090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FAST-CATH INTRODUCER X 2; LIVEWIRE CATHETER; SWARTZ BRAIDED INTRODUCER; TACTICATH QUARTZ CATHETER X 2
• Patient Outcome(s): Death
• Patient Age: 62 YR