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

Model Number	407201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Edema (1820)
Date of Event	06/20/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
Related manufacturing reference:(b)(4).
Additional 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
• Common Device Name: 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
• Report Number: 3008452825-2020-00354
• Device Sequence Number: 3398855
• Product Code: DRC
• UDI-Device Identifier: 05414734205160
• UDI-Public: 05414734205160
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K072278
• 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): 08/04/2020

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: 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
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 60