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

Catalog Number	BD7TCDF4L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and a tilt test was performed.Visual inspection revealed that the tip was broken with internal components exposed.No damages on the electrodes were observed.A tilt test was performed and the tip curve was found within specifications.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The bent tip reported by the customer was confirmed based on the exposed wires condition observed.The potential cause may be attributed to improper handling prior procedure.However, the potential cause cannot be determined with the information available.The instructions for use (ifu) contain the following information: always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the catheter.Ensure the catheter deflects and straightens easily before insertion.Do not use the catheter if excessive 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).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with an ez steer for which biosense webster¿s product analysis lab (pal) identified a broken tip with internal components exposed.It was initially reported by the physician that during a standard svt procedure he was using a 4mm non-nav catheter and upon inserting it into the patient he noticed that the tip was kinked on fluoroscopy.He removed the catheter to inspect the tip and verified that it was kinked.He does not recall using excessive force upon inserting the catheter or during manipulation.The catheter was replaced by the hospital staff.There was no patient injury.There were no exposed wires, sharp or lifted electrode rings and the physician did not feel any resistance during insertion/removal of the catheter.The catheter was no pre-shaped and there were no fragments generated from the reported kink.The customer's reported bent/kinked tip is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 6-nov-2024, the bwi pal revealed that a visual inspection of the returned device found the catheter tip was broken with internal components exposed.These findings were reviewed and reassessed this an mdr reportable malfunction since the integrity of the device has been compromised.

• Brand Name: EZ STEER
• 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: 20820398
• Report Number: 2029046-2024-03847
• Device Sequence Number: 8955346
• Product Code: LPB
• UDI-Device Identifier: 10846835002515
• UDI-Public: (01)10846835002515(17)270426(10)31311266M
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950005/S19
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: BD7TCDF4L
• Device Lot Number: 31311266M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2024
• 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
• Patient Sex: Unknown