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

Catalog Number	D128210
Medical Device Problem Codes	Signal Artifact/Noise (1036); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the pentaray nav eco device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection and electrical test on carto 3 system of the returned device were performed following j&j procedures.A visual inspection was performed, and a spline was found to be detached, leaving internal components exposed.Additionally, the proximal end of the spline was bent.The device was connected to the carto 3 system, and it was recognized and visualized; however, spline broken was not observed on the carto 3 screen.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The spline detached could be related to the noise and the spline bent could be related to the shaft bent reported by the customer therefore the customer complaint was confirmed.The potential cause of the the spline detached and spline bent could be related to excessive force or manipulation during the procedure, however, this cannot be conclusively determined.The instructions for use contain (ifu) the following warning and precaution: 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 carto 3 instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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).
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a pentaray nav catheter for which biosense webster¿s product analysis lab (pal) identified a spline detachment.It was initially reported by the customer that during the operation, the signal interference (noise) was observed on intracardiac (ic) channels while the catheter was in the patient¿s body.Severe interference was observed on the 13 & 14 electrodes.A second device was used to complete the operation.There was no adverse event reported on the patient.The noise was observed only on the carto 3 system and the physician did have other intact ecg signal available to monitor patient heart rhythm.The customer's reported noise issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 28-jul-2025, the bwi pal revealed that a visual inspection of the returned device found a spline was detached, leaving internal components exposed.These findings were reviewed and assessed as an mdr reportable malfunction.

• 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: 22645673
• Report Number: 2029046-2025-02468
• Device Sequence Number: 21002134
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: (01)10846835012248(17)280218(10)31576659L
• 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
• Type of Report: Initial

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: 31576659L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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: CARTO 3 SYSTEM
• Patient Sex: Unknown