MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID; CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE

Catalog Number SEE H10

Device Problem Entrapment of Device (1212)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a webster duo-decapolar catheter which was webster caught in a 6fr sheath requiring a wire and snare for removal.Atrial flutter (afl) ablation was performed using a webster duo-decapolar catheter to treat atrial flutter.Because it was difficult to secure the peripheral venous tract, a 6 fr sheath was inserted via the right common femoral vein before general anesthesia.When the webster duo-decapolar catheter was inserted into the patient's body, it was caught in a 6fr sheath (other manufacture's product).When attempting to remove the webster duo-decapolar catheter, it broke and could not be removed.The webster duo-decapolar catheter was removed using a wire (other manufacture's product) and a snare (other manufacture's product).The procedure was successfully completed using another catheter (product name was unknown).There was no health hazard occurred.

Manufacturer Narrative

Device investigation details: information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If the product or product id numbers are received at a later date, the investigation will be updated as applicable.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.D4.Catalog: unk_webster bipolar - deflectable e1.Initial reporter phone: (b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
• Type of Device: CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE
• 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: 18611447
• MDR Text Key: 334882117
• Report Number: 2029046-2024-00348
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK 6 FR SHEATH; UNKNOWN SNARE; UNKOWN WIRE