MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER® CS EZ STEER CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BD710DF282RTS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported a patient underwent a cardiac ablation procedure which included the use of webster® cs ez steer catheter experienced cardiac tamponade and required surgical intervention.It was reported the medical team placed the cs (coronary sinus) catheter, and after placing it they did the puncture from the right to the left.They then used 2 sheaths in which they placed the pentaray and qdot catheters, but they think the "first puncture on the left side has been tamponade of the wire from a box." they then made a map of the left atrium because the patient was on at (atrial tachycardia).Because the blood pressure was very low, they looked at the echo (echocardiogram) with the transesophageal echocardiogram (tee) and saw the tamponade.Because the blood pressure was too low they started to reanimate the patient.All the product were extracted from the heart, and did a ep (electrophysiology) cardio puncture in the form of a pericardiocentesis.The medical team extracted the fluid of the heart from the outside, and because the patient was still bleeding from the outside, the patient has been going to the operating room.This adverse event is being captured on the webster® cs ez steer catheter.This is because no ablation was performed, only mapping and placement of the cs (coronary sinus) catheter.The placement of the cs catheter appeared to have been prior to the transseptal puncture and the adverse event, thus the possibility of it contributing to this adverse event cannot be excluded.
Additional Manufacturer Narrative
On 27-feb-2024, bwi received additional information indicating the complaint device's lot number of 31141298m.Section d4 has been updated accordingly.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
Per internal review on 5-mar-2024, the product investigation was updated with the manufacturing record evaluation (mre).A manufacturing record evaluation was performed for the finished device number lot 31141298m 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).

• Brand Name: WEBSTER® CS EZ STEER CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 18292822
• Report Number: 2029046-2023-02886
• Device Sequence Number: 6761565
• Product Code: LPB
• UDI-Device Identifier: 10846835002416
• UDI-Public: 10846835002416
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K090898
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2024

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: 09/18/2026
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 31141298M
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 02/27/2024; 03/05/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/27/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• 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: BRK TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; NGEN GENERATOR; NGEN PUMP; PENTARAY CATHETER; QDOT MICRO; SL0 SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown