MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7F282CT
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	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.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a decanav catheter which was reported to have knotted on itself.After the insertion of the catheter, a fold was seen on the shaft of the catheter in the inferior vena cava (ivc) with fluoroscopy.After some manipulation, the physician managed to unfold it.They were able to continue the procedure without any damage to the catheter.No consequence for the patient.Additional information was received indicated they were unable to unknot the catheter, if not, they would not have been able to withdraw it.There was no detachment of components and the event did not result in any internal catheter components exposed or any sharp edges.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a decanav catheter which was reported to have knotted on itself.After the insertion of the catheter, a fold was seen on the shaft of the catheter in the inferior vena cava (ivc) with fluoroscopy.After some manipulation, the physician managed to unfold it.They were able to continue the procedure without any damage to the catheter.No consequence for the patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation on (b)(6) 2025.A visual inspection, microscopic examination, and deflection evaluation of the returned device was performed following j&j procedures.Visual analysis revealed several kinks and bents along the shaft.Microscopic examination of the damage showed stress marks, suggesting that excessive force or manipulation was applied.Then, a deflection test was performed and the curve was not deflecting totally, but not knotted during the test.Due to this condition, the handle of the device was dissected, and the puller wire was observed properly assembled.There were no evidence for stuck, moving or knotted.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Despite, the kinks and bents observed along the shaft, no knotted condition was identified during the analysis.However, the fold on the shaft could be related to the knotted issue reported by the customer; therefore, the complaint was confirmed.The potential cause of the damage on the shaft could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.The instructions for use contain (ifu) the following warning and precaution: always pull the thumb knob back to straighten the catheter tip before insertion or withdrawal of the catheter.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).

• Brand Name: DECANAV
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: 21878690
• Report Number: 2029046-2025-01264
• Device Sequence Number: 8768776
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)251203(10)31519746M
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K080425
• 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
• Report Date (Section B): 04/21/2025

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 Expiration Date: 12/03/2025
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31519746M
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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