MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number BD710DF282CT

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

A picture was received for evaluation following biosense webster's procedures.The picture provided by the customer does not provide sufficient information related to the stuck condition reported by the customer, and therefore no results can be obtained from it.A manufacturing record evaluation was performed for the finished device with lot 30987261m, and no internal actions related to the reported complaint were identified.The customer complaint was not confirmed based on the picture received.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate to find the root cause of the complaint.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer® technology and auto id and the patient experienced a surgical intervention to release an entrapped device and required prolonged hospitalization.It was reported that an agilis guiding wire seems to be stuck on the webster cs catheter.It was an afib case and the incident happened in right atrium, pre transseptal.The physician was not able to get them out and the patient was sent for open heart surgery.Surgery was delayed due to the reported event.The procedure was not successfully completed.The patient went into open heart surgery and sternotomy was provided as intervention.Relevant tests/laboratory data- echo done during case, turned out catheter was stuck in chiari network.The case was cancelled.In physician¿s opinion, the delay did not contribute to a death or a serious injury to the patient.Curve was not jammed.The knob/piston was able to be turned and/or pushed up and down.There was difficulty in removing the catheter.There was no ring, electrode or other physical damage observed at the distal end of the catheter.The adverse event occurred on (b)(6) 2023.It was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was patient condition related.The patient fully recovered (no residual effects).Patient required extended hospitalization because of the adverse event due to sternotomy recovery.The medical device entrapment is mdr reportable.Since the event is life threatening and it required 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 and mdr reportable.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 19-may-2023.The device evaluation was completed on 25-may-2023.It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer® thechnology and auto id and the patient experienced a surgical intervention to release an entrapped device and required prolonged hospitalization.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.According to pictures provided by the customer, the photo does not provide sufficient information related to the stuck condition reported by the customer, and therefore no results can be obtained from it.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 30987261m and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The physician¿s opinion on the cause of this adverse event was that it was patient condition related.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 16948543
• MDR Text Key: 315440543
• Report Number: 2029046-2023-01065
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K090898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 30987261M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK ABBOTT AGILIS SHEATH 8.5 FR; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male