MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7F282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation with a decanav catheter and an octaray mapping catheter.The patient experienced a pericardial effusion that required a pericardiocentesis.A pericardial effusion was noticed with the patient during the procedure.The pericardial effusion was discovered while they were mapping the left atrium.The physician believes the pericardial effusion occurred when they were going transeptal.They noticed the patient¿s blood pressure dropping and confirmed it with intracardiac echocardiography (ice) and discovered the pericardial effusion.A pericardiocentesis procedure was then performed on the patient.The patient¿s last known status was stable.They had the generator ready to go but never started ablation.A decanav catheter, an octaray catheter and a sterilmed soundstar were used during the procedure.Additional information was received.The physician believes the cause of the adverse event was the transseptal puncture.He said the patient had an unusually small heart.One transseptal puncture.To go transseptal, the physician used the versacross steerable access sheath by baylis.The physician performed a pericardiocentesis.The patient¿s condition is improved and planning to reschedule the ablation procedure when fully recovered.No ablation was performed prior to noting pericardial effusion.No evidence of steam pop.The event was first noted during the mapping phase, and the physician believes it was caused by the transseptal.An irrigated catheter was not used in the event.The patient did not require cardiac surgery.Since the event was discovered during mapping, it was assessed to report it under both the mapping catheters (decanav catheter and octaray mapping catheter).
Additional Manufacturer Narrative
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 number lot 31434618m and no internal action related to the complaint was found during the review.If the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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).

• Brand Name: DECANAV
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 20755661
• Report Number: 2029046-2024-03765
• Device Sequence Number: 15559178
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)250901(10)31434618M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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 Expiration Date: 09/01/2025
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31434618M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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: BAYLIS VERSACROSS STEERABLE ACCESS SHEATH.; OCTA,LNG,48P,3-3-3-3-3,F-CURVE.; STERILMED SOUNDSTAR CATHETER.; UNK_NGEN RF GENERATOR.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown