MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160901

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2023

Event Type  Injury  

Event Description

It was reported from a bwi sponsored study that a patient underwent paroxymal afib cardiac ablation procedure that included the use of octaray, perseid, 48p, 2-2-2-2-2, d-curve mapping catheter.The patient experienced intermittent scotoma (ae1) that required hospitalization.External reference: (b)(4).Index procedure on (b)(6) 2023 with general anesthesia that included a double transseptal access and pre-ablation mapping of la with octaray, perseid, 48p, 2-2-2-2-2, d-curve catheter that included left superior pulmonary vein (lspv), left inferior pulmonary vein (lipv), right superior pulmonary vein (rspv), and right inferior pulmonary vein (ripv).Ablation was performed on lpv and rpv for pvi.During rpv ablation with the ablation catheter an impedance error was noted.On (b)(6) 2023, patient experienced intermittent scotoma (ae1) and visited the emergency room.The study principal investigator (pi) categorized the event severity as moderate and serious as defined by inpatient or prolonged hospitalization with admission of (b)(6) 2023 and discharge of (b)(6) 2023.Per pi, relationship to biosense webster ce mark devices octaray catheter is possible; and relationship to study procedure is possible.The event is categorized as expected/anticipated and the outcome is not recovered/not resolved.No specific intervention/treatment was provided.It is noted that the patient visited the emergency room on (b)(6) 2023 and marked as admitted for same adverse event of intermittent scotoma (ae1).No further information provided about this event.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 04-may-2023 and 26-may-2023, additional information was received indicating that the adverse event (ae1) term of intermittent scotoma was updated to migraine aura.The adverse event is not related to any devices and not related to the study procedure.As such, this event is no longer considered to be mdr reportable.Therefore, the h 6.Health effect - clinical code, h 6.Health effect - impact code and h 6.Medical device problem code were updated.Since this event has already been reported to fda, biosense webster inc.Will continue to submit supplemental 3500a reports to the fda with any updates even though this event is no longer considered mdr reportable.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 30997447l number, and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

• Brand Name: OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16811985
• MDR Text Key: 313989145
• Report Number: 2029046-2023-00885
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

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
• Device Operator: Health Professional
• Device Model Number: D160901
• Device Catalogue Number: D160901
• Device Lot Number: 30997447L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: THCL SMTCH SF BID TC, D-F, IDE; TRUPULSE GENERATOR, WW
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 87 KG