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

Catalog Number	D128208
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav which did not irrigate well during use on the patient.It was initially reported by the customer that the catheter did not irrigate well, the irrigation did not pass through the catheter.We changed it, and the problem was solved.The customer's reported occlusion 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(b)(6) 2025, additional information was received indicating that during the first moments of use, the catheter perfused normally with no error messages.After approximately one minute of perfusion, the external pump displayed an obstruction/flow-block message, indicating that perfusion was not passing through the catheter.For troubleshooting the perfusion flow rate was decreased to the minimum setting, but the obstruction message persisted.The catheter was visually inspected to assess potential obstruction.Although no visible blockage was identified, the perfusion solution did not appear to exit through the catheter.The catheter was replaced with a new pentaray.With the new catheter and the same perfusion settings, the system functioned normally with no obstruction messages.Based on the additional infomration received indicating the irrigation issue occurred during use on the patient, the event was reassessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
Additional Manufacturer Narrative
On 14-jan-2026, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav which did not irrigate well during use on the patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection and irrigation test of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.An irrigation test was performed, and the catheter failed the test since no flow was observed.Afterwards, an aluminum wire was introduced in the luer hub, and the wire got stuck at the tip area.The tip was dissected and the irrigation tube was inspected, and it was found the irrigation tube folded into a "z" shape in the transition between the tip to the sheath.This failure mode was identified as manufacturing related.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The irrigation issue reported by the customer was confirmed.The root cause of the folded irrigation tubing is traced to the manufacturing process.The instruction for use (ifu) contain the following warning and precautions: flush the catheter with heparinized saline prior to insertion into the body.Always follow standard practices of using a continuous drip of anticoagulant fluid under pressure through the proximal luer connector when the device is in the body.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 23854651
• Report Number: 2029046-2025-04242
• Device Sequence Number: 20104033
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: (01)10846835012224(17)280225(10)31584664L
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup,Followup

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: 31584664L
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 02/07/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/23/2026; 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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: PUMP.
• Patient Sex: Unknown