MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160901

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 07/27/2022

Event Type  Injury  

Event Description

It was reported that an unknown male patient underwent a persistent atrial fibrillation (afib) ablation procedure with a octaray, perseid, 48p, 2-2-2-2-2, d-curve and a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced double images and suffered cerebral ischemic lesions after and ablation procedure.The patient reported he sees double images after pulmonary vein isolation (pvi) procedure with octaray.Physician performed a mrt and ct.He found sub-acute cerebral ischemic lesions.A smarttouch sf (df d134805) ablation catheter was used; but physician supposed that the octaray (d160901) catheter could be the cause.This adverse event was discovered post use of biosense webster products.The physician has no idea where the cause came from.It could be the catheter or the patient's health constitution.However, the temporal relationship to the examination is striking.Intervention being provided was afib pvi.The patient required extended hospitalization because of the adverse event for observation.A osypka hat 500® generator system was used.Conservatively the smart touch and octaray will be considered reportable as ablation was performed and the physician supposed that the octaray could be the cause so it is difficult to determine which device contributed to the event.This report is for the octaray.The smart touch was reported in manufacturer report number 2029046-2022-02013.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 15-sep-2022, bwi received additional information which clarified ¿the temporal relationship to the examination is striking".Clinical in charge stated that the night after the carto examination, patient was complaining about headache.An mri of the head was carried out during which the lesions were visible.It was also visible that the lesions were "fresh" (new).In terms of time-frame and type of intervention it is likely that this (i.E.The intervention) could have caused the issue / explains the noticed effect.Conservatively the smart touch and octaray will be considered reportable as ablation was performed and the physician supposed that the octaray could be the cause so it is difficult to determine which device contributed to the event.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 MAPPING CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15308464
• MDR Text Key: 298772980
• Report Number: 2029046-2022-02014
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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: OSYPKA HAT 500® GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male