MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCFL174HS
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Off-Label Use (1494); Device Contamination with Body Fluid (2317); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a navistar catheter and the physician considered that the char was excessive.The navistar (4mm) was used for an atrial tachycardia (at) ablation right sided.After several burns, physician complained that power / temperature ratio was bad and took the catheter out.Visible charring on tip after 60w/60°c ablation setting.A thermocool was used to treat the patient further.Procedure delayed by 4 minutes.There was no patient consequence reported.Additional information was received on 15-apr-2025.The physician considered that the char was excessive.The physician did not really consider that the amount of char caused a potential risk to this patient since it was a right-sided ablation.The system did not present any error message; just bad power output (high temperature and low power) after several probably because of already charred tip.Used non-irrigated catheter.The generator threshold was 60w/60'c.The noted temperature, impedance and power were normal in the beginning.Worse after several burns (high power 60'c and bad power ~ 15w).Standard heparin bolus before ablation, no act because right sided ablation only.Used an osypka generator (physician knows that it was off label as do not guarantee conformity of carto in combination with generator).Osypka pump not used since it was a non-irrigated catheter.This event was originally considered non-reportable, however, bwi became aware on 15-apr-2025 that the physician considered that the char was excessive and have reassessed the event as reportable.The awareness date for this record is 15-apr-2025.
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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 06-jun-2025.The 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 reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a navistar catheter.The navistar (4mm) was used for an atrial tachycardia (at) ablation right sided.After several burns, physician complained that power / temperature ratio was bad and took the catheter out.Visible charring on tip after 60w/60°c ablation setting.Additional information was received.The physician considered that the char was excessive.Used an osypka generator (physician knows that it was off label as do not guarantee conformity of carto in combination with generator).The device evaluation was completed on 24-jun-2025.The device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection, microscopic examination, temperature, and impedance test of the returned device were performed following j&j procedures.Visual inspection revealed char residues at the bottom of the dome.A temperature and impedance test was performed, and no issues were observed.It was identified that an osypka generator was used during the procedure.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No temperature issues were observed; however, the char, temperature and off label use issues reported by the customer were confirmed due to the char observed.The potential cause of the char could be related to the procedure and use of a different equipment; however, this could not be conclusively determined.The instruction for use contains the following recommendations: connect the catheter to the interface cables, the carto ® system, a compatible rf generator, and standard recording equipment using the appropriate interface cables; in the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn and the tip electrode cleaned of coagulum before rf energy is reapplied.Use only sterile saline and gauze pad to clean the tip.As part of johnson & johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: usage problem identified (c23) / investigation conclusions: cause traced to user (d11) / component code: appropriate term/code not available (g07002) were selected as related to the customer¿s reported ¿off label use¿ issue.In addition, biosense webster inc.Analysis finding of the ¿off label use¿ issue.Investigation findings: contamination of environment by device (c1503) / investigation conclusions: cause traced to user (d11) / component code: dome (g04046) were selected as related to the customer¿s reported ¿physician considered that the char was excessive" and "power / temperature ratio was bad¿ issues.In addition, biosense webster inc.Analysis finding of the ¿char residue¿ issue.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: NAVISTAR
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 21991036
• Report Number: 2029046-2025-01493
• Device Sequence Number: 15531761
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: (01)10846835000610(17)280206(10)31559337M
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P990025
• 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
• Report Date (Section B): 07/16/2025

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: NS7TCFL174HS
• Device Lot Number: 31559337M
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 06/24/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/09/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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: OSYPKA GENERATOR.; UNK_CARTO 3.
• Patient Sex: Unknown