MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710DF282RTS
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	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 upon receipt of the new webster cs catheter product, it was noticed that the product packaging was damaged.The caller reported that the product box was opened at the top, and the box itself appears "squished and torn." the caller reported that upon inspection, it was confirmed that there is a rip in the sterile pouch seal of the webster cs catheter as well.There was no patient consequence.
Additional Manufacturer Narrative
On 7-jan-2026, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that upon receipt of the new webster cs catheter product, it was noticed that the product packaging was damaged.The caller reported that the product box was opened at the top, and the box itself appears "squished and torn." device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection of the returned device was performed following j&j procedures.The device was inspected, and no physical damage was observed.Customer reported the packaging was damage upon receipt of the catheter; however, the package and the pouch were not returned for analysis.Due this condition further investigation was not possible to perform.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The package issues reported by the customer were not confirmed, due to the package or pouch were not returned for analysis.The potential cause of the issue cannot be established.The instructions for use contain (ifu) state the following in the sterilization and use-by date section: do not use the catheter if the packaging or catheter appears damaged.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: WEBSTER CS
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23905728
• Report Number: 2029046-2025-04322
• Device Sequence Number: 21130729
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: (01)10846835002416(17)281019(10)31788037M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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,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: BD710DF282RTS
• Device Lot Number: 31788037M
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 01/19/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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
• Patient Sex: Unknown