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

Catalog Number	D128210
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture was received for evaluation following johnson & johnson medtech's procedures.According to the picture provided by the customer, a bent electrode is observed.A thin filament is observed in one spine, however, it cannot be determined whether this material originated from the catheter, as no rupture was observed in that area.A manufacturing record evaluation was performed for the finished device number lot 31571205l and no internal action related to the complaint was found during the review.The customer complaint was confirmed based on the picture received.The device has not been received for analysis and a root cause is unable to be assigned based on the current evidence.H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.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 an atrial fibrillation (afib) paroxysmal ablation procedure with a pentaray nav.Initially, it was indicated that during the operation, the tip of the device was found to have been damaged.A second device was used to complete the operation.There was no adverse event reported on the patient.With the initial information available, this event was assessed as non mdr reportable.However, on 12-jul-2025, additional information was received which indicated that the damage resulted in wires being exposed.Therefore, the event was re-assessed as mdr reportable with an awareness date of 12-jul-2025.
Additional Manufacturer Narrative
The device was received for evaluation on 05-aug-2025.It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a pentaray nav, and the tip of the device was found to have been damaged.Additional information indicated that the damage resulted in wires being exposed.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and fourier transform infrared spectroscopy (ft-ir) of the returned device were performed following j&j medtech procedures.Visual analysis revealed that some electrodes were bent and lifted, and one had a plastic attached.A fourier transform infrared spectroscopy was performed and revealed that the plastic attached in the electrode was polytetrafluoroethylene (pt-fe).A manufacturing record evaluation was performed for the finished device number lot 31571205l and no internal action related to the complaint was found during the review.The pt-fe and lifted electrodes observed could be related to the internal components exposed issue reported by the customer; therefore, the complaint was confirmed.The pt-fe in the spline and bent and lifted electrodes could be related to the manipulation of the device with a sheath during the procedure, however, this could not be conclusively determined.The instructions for use contain the following recommendations: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded backward toward the handle.Collapse the spines together using the insertion tube prior to insertion; the catheter is recommended for use with an 8 f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25 mm in diameter; do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.Do not bend the spines backward.After insertion, slide the insertion tube back toward the handle.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: 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: 22696546
• Report Number: 2029046-2025-02527
• Device Sequence Number: 20896850
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: (01)10846835012248(17)280212(10)31571205L
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/02/2025

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 Catalogue Number: D128210
• Device Lot Number: 31571205L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/03/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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: SYNAPTIC LEFT SHEATH
• Patient Sex: Unknown