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

Catalog Number	D160901
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.Investigation is in progress, once completed a supplemental will be submitted.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).
Event or Problem Description
It was reported that during cardiac ablation with an octaray mapping catheter, the patient experienced a cardiac tamponade treated with pericardiocentesis and required prolonged hospitalization.During pre-mapping with the octaray mapping catheter, the patient's blood pressure decreased.Effusion was confirmed by echocardiography, and pericardiocentesis was performed, but the bleeding could not be stopped, and the blood pressure remained unstable, leading to transfer of the patient to another facility.The timing of the perforation remains unclear.Possible occurrences include during insertion into the coronary sinus (cs) or during the brockenbrough.Since the cs-ostium was wide and insertion was easy, the perforation likely occurred during brockenbrough use.The physician's opinions on the relationship between the event and the product were no comment.It was predicted to be a perforation during brockenbrough.Prolongation of hospital stay was noted.No abnormalities observed prior/during use of the product.Additional information was received on 10-jul-2025.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The physician suspected that a cardiac perforation might have occurred during transseptal puncture.The intervention provided was pericardiocentesis was performed.Then, the patient was transferred to another facility.No ablation was performed.Since the issue was related to the octaray mapping catheter, it was not related to the generator.One catheter was used.No error messages observed on biosense webster equipment during the procedure.Additional information was received on 23-jul-2025.The patient will be discharged from the hospital in this week.One transseptal site was used, transseptal puncture was performed by accusafe needle.
Additional Manufacturer Narrative
Additional information was received on 08-aug-2025.Cardiac perforation was only suspected and not confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation was completed on 04-sep-2025.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 31604684l number, and no internal action was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.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
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22703208
• Report Number: 2029046-2025-02534
• Device Sequence Number: 21119737
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: (01)10846835021141(11)250318(17)280317(10)31604684L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2025

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: Health Professional
• Device Catalogue Number: D160901
• Device Lot Number: 31604684L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 09/04/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/03/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCUSAFE NEEDLE.; UNK GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: Asian