MAUDE Adverse Event Report: BIOSENSE WEBSTER INC ISMUS; CATHETER, ELECTRODE RECORDING

Catalog Number	D7R20P14RT
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 20-mar-2025, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with an ismus catheter and the patient experienced device entrapment that required snare removal.It was reported that the isthmus catheter got caught on itself while it was inside of the body.It was believed the catheter was caught with some tissue and was wrapped around the shaft of the catheter.The one electrode on the catheter could not be freed.A snare was inserted in the body to pull the catheter out of the main sheath.There were no visible tissue on the catheter after it was removed from the body.They used the ultrasound machine extensively to confirm there was no injury to the heart, patient or any groin issues.It was unknown if any medical intervention was provided for the patient.It was unknown what led up to the discovery of the device patient complication.The ismus catheter was replaced with a decanav catheter and the procedure continued.They requested the catheter to be sent in for examination to see if there was anything on the electrode, or if there was anything pultruding that could have caught the tissue that could have caused the issue.In a more detailed response, it was reported that during insertion of the ismus catheter into the body the physician stated the catheter was ¿stuck¿ in the eustachian valve of the inferior vena cava (ivc).The physician attempted multiple maneuvers to free the catheter without success.He then placed the farapulse catheter up the ivc attempting to free the ismus catheter.This was also unsuccessful.He then used a snare device and was successful in freeing the catheter from the eustachian valve.However, the distal end of the catheter was ¿stuck¿ to the catheter.When he advanced the catheter, the distal end would slide towards the more proximal end of the catheter.He then decided to slowly pull the catheter towards the femoral sheath.When he reached the sheath the distal end of the catheter released from the catheter and the entire catheter was removed from the body.The physician felt that a small piece of the eustachian valve may have encircled the distal end of the catheter holding it to the shaft of the catheter.As previously reported, extensive 2d ice was done and no abnormalities were seen.He progressed with the procedure without complications.Following the procedure the patient was returned to their room and was discharged later in the day.The patient did not require extended hospitalization.
Additional Manufacturer Narrative
On 7-apr-2025, additional infomration was received confirming the catheter tip and electrodes/rings of the isthmus did not have any visible physical damage.Device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and dimensional inspection of the returned device were performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.The dimensional test was performed and the outer diameters of the electrodes and shaft were found within specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The entrapment issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use of the device contain the following recommendations: do not use excessive force to advance or withdraw the catheter when resistance is encountered.As part of johnson & johnson medtech¿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 ref.# (b)(4).

• Brand Name: ISMUS
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 21727163
• Report Number: 2029046-2025-00957
• Device Sequence Number: 9437197
• Product Code: DRF
• UDI-Device Identifier: 10846835005950
• UDI-Public: (01)10846835005950(17)280115(10)31541477L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D7R20P14RT
• Device Lot Number: 31541477L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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: CARTO 3 SYSTEM.; FARAPULSE CATHETER.; UNKNOWN DECANAV.
• Patient Sex: Unknown