MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number 407200

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

Patient Problem Stroke/CVA (1770)

Event Date 04/26/2020

Event Type  Injury  

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: 3005334138-2020-00200, 3008452825-2020-00251, 3005334138-2020-00201, 2182269-2020-00048.Two days following an ablation procedure, the patient developed a cerebrovascular accident.The circumferential four pulmonary vein isolation and cavotricuspid isthmus ablation procedure was performed on (b)(6) 2020 with no reported issues.The patient was anticoagulated during the procedure with an active clotting time value of greater than 300, and there were no performance issues with any abbott device.On (b)(6) 2020 a head ct and mri were performed, revealing an acute-to-subacute cerebral infarction over the right frontal and temporal opercula region.It was suspected that there was a thrombus in the cortical bifurcation of the inferior segment of the right middle cerebral artery (mca).The patient was hospitalized for iv fluids and anticoagulants, remaining in stable condition.A repeat head ct revealed no intracranial hemorrhage and the patient was discharged on (b)(6) 2020 with no residual neurological deficits.

• Brand Name: BRK TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10088456
• MDR Text Key: 192040244
• Report Number: 3008452825-2020-00252
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205092
• UDI-Public: 05414734205092
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K072278
• 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
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 7274531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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: ADVISOR HD GRID CATHETER; LIVEWIRE CATHETER; SWARTZ BRAIDED INTRODUCER; TACTICATH SE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 54