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

Catalog Number	BN7TCDF4L
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia ablation procedure with an ez steer catheter and the packaging was completely damaged.The medical team confirmed that both the outer and inner packaging covering the catheter were damaged.The damages were discovered as they were setting up for the procedure.The procedure moved forward with another catheter.No patient consequences were reported.
Additional Manufacturer Narrative
The product investigation was completed based on a received photograph of the device.Device investigation details: a picture was received for evaluation following johnson & johnson medtech's procedures.According to the picture provided by the customer the outer box packaging was observed torn and crushed.However, the pouch of the device is not observed on the photo provided by the customer and is not possible to confirm a damage in the pouch seal.The potential cause of the packaging damage cannot established.A manufacturing record evaluation was performed for the finished device number lot 31849276m and no internal action related to the complaint was found during the review.The customer complaint was confirmed based on the photo received.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 reference number: (b)(4).
Additional Manufacturer Narrative
On 19-mar-2026, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a supraventricular tachycardia ablation procedure with an ez steer catheter and the packaging was completely damaged.The medical team confirmed that both the outer and inner packaging covering the catheter were damaged.The damages were discovered as they were setting up for the procedure.The procedure moved forward with another catheter.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection of the returned device was performed.Visual inspection revealed knob detached from the rocker arm on the handle of the device.No original packaging was returned to analysis site; however, the detached knob could be related to the packaging issue reported by the customer.Welding residue was found on the handle, showing that rocker arm was previously attached to the device; suggestive of the device being properly manufactured previous to the detachment.A manufacturing record evaluation was performed for the finished device number lot 31849276m and no internal action related to the complaint was found during the review.The packaging issue reported by the customer was confirmed.The potential cause of the knob detached could be related to the shipping process during the transportation of the device; however this cannot be conclusively determined.The open pouch issue could not be analyzed due to no original packaging was returned to analysis site.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 reference number: (b)(4).

• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24633157
• Report Number: 2029046-2026-00912
• Device Sequence Number: 18388822
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(17)290114(10)31849276M
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: BN7TCDF4L
• Device Lot Number: 31849276M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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