MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160904
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Picture evaluation details.A picture was received for evaluation following johnson & johnson medtech's procedures.According to the picture provided by the customer, one spline was observed detached from the tip leaving internal components exposed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a pulmonary vein isolation (pvi) procedure with an octaray mapping catheter.They used an octaray mapping catheter with sl0 sheath for a left atrium (la) map.The sl0 sheath was sucking air; therefore, the physician pulled the octaray mapping catheter out of the sheath to check the sheath.As he pulled out the octaray mapping catheter, he noticed that some coverage / plastic piece of the octaray mapping catheter spline was falling off one of the splines and he was then holding a part of the spline cover in his hand.No material was lost in the patient.However, he then lost it on the table or floor.Therefore, it can not be sent back in the complaint box.Unknown if the procedure was successfully completed.There were no consequences for the patient.Only delay of 5 minutes.
Additional Manufacturer Narrative
It was reported that a patient underwent a pulmonary vein isolation (pvi) procedure with an octaray mapping catheter.They used an octaray mapping catheter with sl0 sheath for a left atrium (la) map.The sl0 sheath was sucking air; therefore, the physician pulled the octaray mapping catheter out of the sheath to check the sheath.As he pulled out the octaray mapping catheter, he noticed that some coverage / plastic piece of the octaray mapping catheter spline was falling off one of the splines and he was then holding a part of the spline cover in his hand.No material was lost in the patient.However, he then lost it on the table or floor.Therefore, it can not be sent back in the complaint box.Unknown if the procedure was successfully completed.There were no consequences for the patient.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 25-sep-2025.Visual inspection, microscopic examination and dimensional test were performed of the returned device were performed following j&j procedures.Visual analysis revealed that one spline was observed fully separated from the tip leaving internal components exposed.Dimensional test was performed and the device measurements were found within specifications.A manufacturing history record was performed for the finished device batch number, and no internal actions were identified.The tip issue reported by the customer was confirmed.The potential cause of the issue could be related to excessive force or manipulation during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) states the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered.Careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement and placement should be done through a guiding sheath under direct imaging guidance such as fluoroscopy or ultrasound.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: OCTARAY MAPPING CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 22743586
• Report Number: 2029046-2025-02614
• Device Sequence Number: 7283040
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(11)241008(17)251007(10)31468349L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193237
• 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,Followup
• Report Date (Section B): 10/20/2025

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 Expiration Date: 10/07/2025
• Device Catalogue Number: D160904
• Device Lot Number: 31468349L
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK SL0 SHEATH.
• Patient Sex: Unknown