MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAVIGATIONAL 4MM; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BN7TCDF4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient receiving a cardiac ablation procedure including use of ez steer navigational 4mm catheter experienced cardiac tamponade and required pericardiocentesis.It was reported that a pericardial effusion was noticed after the procedure was completed.After the procedure was completed, the patient's blood pressure dropped a lot.After coming from sedation, the patient complained of jaw pain.The caller reported that the pericardial effusion was confirmed with an external ultrasound probe.The pericardiocentesis was performed and that at least 180 ml of fluid was removed from the patient.The patient was reported to be in stable condition.The physician was out of the normal quad catheters that he usually uses and the physician used a woven non-bwi catheter during the procedure instead.The physician noticed that the woven non-bwi catheter was stiff when using it inside the patient and that the physician thought that a perforation and pericardial effusion were caused by the woven non-bwi catheter.The medical team had to cardiovert the patient 3 times and that the physician believed the woven non-bwi catheter poked through during one of the cardioversions.Per internal review, it was determined that since ablation was completed, the ablation catheter cannot be completely dissociated a contributor to the cause of pericardial effusion even though the speculated cause was a non-bwi catheter.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.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore 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).

• Brand Name: EZ STEER NAVIGATIONAL 4MM
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 17841470
• Report Number: 2029046-2023-02189
• Device Sequence Number: 17953798
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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: BN7TCDF4L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown