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

Catalog Number	D128211
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) procedure with a pentaray nav catheter and one of the splines of the pentaray nav catheter got stuck sheath has been physically.Managed to complete the procedure with the same catheter.No patient consequences.No delay.Additional information was received on 10-mar-2026 which clarified that at the end of the procedure, while pulling the pentaray nav catheter back into the sheath, one spline became loose.However, it was pulled out of the patient¿s body completely together with the sheath.No patient injuries or consequences.Additional information was received on 12-mar-2026.The damage did result in a wire exposed.The customer stated there was resistance when trying to pull the catheter out of the sheath at the "heigth" of groin.Detachment was total.Detached section was stuck in sheath.After looking at the fluoroscopy, no further parts were visible inside the patient.Additional information was received on 15-mar-2026.Occurred during catheter exchange within the two sl0 sheaths (abbott).When advancing the catheter out of the sheath, as usual up to catheter deployment, no abnormalities.Subsequently, restricted maneuverability of the catheter, and an attempt was made to retract the catheter back into the sheath with minimal resistance.Thereafter, an insulation defect of the affected arm was noticed, no signals on monitor, noise artifact.The catheter was retrieved, and the insulation defect was noticed radiological imaging detected the insulation fragment at the tip of the sl0 sheath.It was retracted into the right atrium (ra) and removed from the patient.Fortunately, no negative consequences for the patient.Ablation was completed as planned using a second pentaray catheter.No foreign material remained inside patient.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).The picture evaluation details: a photo was received for evaluation following johnson & johnson medtech (j&j medtech) procedures.According to the pictures provided by the customer, the spline is observed in one of the holes of the sheath.In addition, it is observed that the spline is detached with internal components exposed.This could be related to the resistance issue experienced by the customer.The potential cause to the issue could be related to the force applied when trying to remove the device from the sheath, this is not conclusive determined.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 photo 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.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Investigation findings code of ¿appropriate investigation findings term/code not available (c22) represents photo 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).

• 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: 24778657
• Report Number: 2029046-2026-01111
• Device Sequence Number: 6134581
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(17)281201(10)31819962L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: D128211
• Device Lot Number: 31819962L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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