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

Catalog Number	D160901
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a octaray mapping catheter and after the procedure's completion the catheter was removed from the competitor company's sheath and a fine thread was observed coming out from the spine.Because the thread was entangled with the spine, it was unclear whether the thread came from the octaray or from another material, such as inner material peeled off from the sheath.The physician did not experience any resistance when introducing or retracting the catheter.There were no damages noted on the octaray either.No patient consequences were reported.
Additional Manufacturer Narrative
The product investigation was completed based on a received photograph of the complaint device.Device investigation details: a picture was received for evaluation following johnson & johnson medtech (j&j medtech) procedures.According to the pictures provided by the customer, a plastic thread was observed entangled to the splines of the octaray catheter; however the source of this material remains unknown.The potential cause of the material on the splines of the catheter may have been related to the handling of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device number 31678035l, and no internal actions related to the reported complaint were identified.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.This product issue will be addressed through the quality system 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 paroxysmal supraventricular tachycardia ablation procedure with a octaray mapping catheter and after the procedure's completion the catheter was removed from the competitor company's sheath and a fine thread was observed coming out from the spine.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and fourier transform infrared spectroscopy (ft-ir) of the returned device were performed following j&j medtech procedures.Visual analysis revealed that some electrodes were bent and lifted, and one had a plastic attached.A ft-ir was performed and revealed that the plastic attached in the splines was polytetrafluoroethylene (pt-fe).A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The pt-fe and lifted electrode observed could be related to the event reported by the customer, the complaint was confirmed.The pt-fe in the spline and bent and lifted electrode could be related to the manipulation of the device with a sheath during the procedure, however, this could not be conclusively determined.The instructions for use contain the following recommendations: the catheter is recommended for use with an 8.5f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with a transseptal sheath featuring side holes larger than 1.25 mm in diameter; do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded back toward the handle.Collapse the spines together using the insertion tube prior to insertion; do not pre-bend the catheter.Excessive bending or kinking of the catheter shaft or spines may damage lead wires and cause loss of electrode function; do not use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered.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.No: (b)(4).

• Brand Name: OCTARAY MAPPING CATHETER
• 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: 23410305
• Report Number: 2029046-2025-03606
• Device Sequence Number: 21103367
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: (01)10846835021141(11)250605(17)280604(10)31678035L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193237
• 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): 10/28/2025

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: D160901
• Device Lot Number: 31678035L
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: BOSTON SCIENTIFIC SHEATH; VERSACROSS SHEATH
• Patient Sex: Unknown