MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number	F6QF252RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial tachycardia ablation procedure with a webster and the patient experienced pericardial effusion that required pericardiocentesis and drain placement.It was reported that during an atrial tachycardia case, a pericardial effusion was noticed.The physician noticed when going transseptal that the intracardiac echocardiography (ice) images didn¿t look the way they should.This caused them to notice the drop in blood pressure so they checked for any complications.No ablation had been completed when the injury occurred.The pericardial effusion was confirmed by ice.The medical intervention provided was a pericardiocentesis.The patient fully recovered, however, required extended hospitalization (patient had to spend 2 nights in the hospital waiting for the drain to be removed and watching to make sure she was completely recovered).The physician believed the rv was perforated using the quad catheter during the transseptal puncture because the effusion was bigger on the right side of the heart.
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are 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.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 ref.# (b)(4).

• Brand Name: WEBSTER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• 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: 20447496
• Report Number: 2029046-2024-03397
• Device Sequence Number: 15231472
• Product Code: LDF
• UDI-Device Identifier: 10846835008012
• UDI-Public: 10846835008012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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

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: F6QF252RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; BAYLIS VERSACROSS SHEATH AND WIRE; SOUNDSTAR ECO SMS 8F CATHETER; UNK_NGEN RF GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White