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

Catalog Number	D128208
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.A picture was received for evaluation following johnson & johnson medtech's procedures.According to picture provided by the customer, a foreign material like a fiber plastic was observed attached to the tip of the pentaray catheter; no damage on the tip or electrodes is observed.The source of origin of the foreign material could not be determined based on the picture.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis, and the root cause is unable to be assigned based on the current evidence.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 reference number:(b)(4).
Event or Problem Description
It was reported that a patient underwent a persistant atrial fibrillation (afib) cardiac ablation procedure, with a pentaray nav, and fibers were noticed around the spline.During mapping with pentaray catheter, the maneuverability suddenly changed ("got worse") and the patient had some extra beats, which he did not have prior to that.The catheter was pulled immediately, and fibers were noticed around the splines (origin unclear).The surgery was not delayed.The catheter was ¿dismissed and changed¿.The catheter was exchanged, and the procedure was successfully completed.There was no patient consequence.Additional information indicated that there was no talk about resistance, but the catheter was already inside the chamber and actively mapping.The patient did not require extended hospitalization.
Additional Manufacturer Narrative
Additional information was received on 15-jan-2026.It was reported that a biosense webster sheath was used which was a vizigo sheath.Therefore, the vizigo sheath is now considered the suspected device and the pentaray is no longer considered the suspected device in this event.As such, h 6.Medical device problem code has been updated to adverse event without identified device or use problem (a24).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: PENTARAY NAV
• 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: 24023781
• Report Number: 2029046-2026-00096
• Device Sequence Number: 13410424
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: (01)10846835012224(17)280918(10)31771193L
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K123837
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: D128208
• Device Lot Number: 31771193L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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: NGEN PUMP, EU CONFIGURATION; NGEN RF GENERATOR
• Patient Sex: Male
• Patient Race: White