MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number 407201

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

Patient Problems Stroke/CVA (1770); Edema (1820)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.

Event Description

Related manufacturing reference: 3005334138-2020-00305, 3005334138-2020-00306, 2182269-2020-00067, 3008452825-2020-00355, 3005334138-2020-00307.Following an ablation procedure, a possible stroke and cerebral edema occurred.The ablation was completed successfully with no abnormalities.The patient was transferred to coronary care unit to be followed.The evening of the ablation procedure, assessment and investigation of acute ischemic stroke was administered.The following day, the patient withdrew from the clinical study.A ct on (b)(6) 2020 revealed a small caliber of distal m1 and decreased vascularities of the left side middle cerebral artery, compatible with acute occlusion of the m1 middle cer.The patient underwent a mechanical thrombectomy and was stabilized.A dyna-ct showed no obvious intracerebral hemorrhage (ich).The patient was followed in ncua.Altered mental status was noted and a brain ct showed brain edema without ich.Emergency decompressive craniectomy and icp insertion was administered.Prior to procedure, it was confirmed there was no thrombus and the active clotting time during the procedure was between 200 and 270.Though there is no indication a device caused the stroke or edema, the cause of the adverse events is unknown.There were no performance issues with any abbott device.

Event Description

Related manufacturing reference:(b)(4).

Manufacturer Narrative

Additional information: b5, e1, g4, g7, h2, h3, h6, h10.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 stroke and cerebral edema could not be conclusively determined.

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 10307215
• MDR Text Key: 199852968
• Report Number: 3008452825-2020-00354
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (y/n): N
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2022
• Device Model Number: 407201
• Device Catalogue Number: 407201
• Device Lot Number: 7108604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; FAST-CATH INTRODUCER; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE; ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; FAST-CATH INTRODUCER; LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 60