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

Catalog Number	D160903
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a octaray mapping catheter for which biosense webster¿s product analysis lab (pal) identified a electrode damaged.The electrode was observed lifted and displaced from its original position leaving internal components exposed.It was initially reported by the customer that the octaray was used in the procedure in conjunction with the vizigo sheath and there were no problems with the octaray itself.As such, the initial reported event with the octaray mapping catheter was not considered to be mdr reportable.On (b)(6) 2025, the bwi pal revealed that a visual inspection of the returned device found an electrode was observed lifted and displaced from its original position leaving internal components exposed.These findings were reviewed and assessed as mdr reportable as a malfunction since the integrity of the device has been compromised.
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection of the returned device was performed following j&j procedures.Visual inspection was performed, and damage was observed on the splines and rings.It was observed that one spline was stretched and two electrodes were damage.An electrode was observed lifted, and displaced from its original position leaving internal components exposed.The damage on the electrode and the spline, could be related to excessive force or manipulation during the procedure, however, this cannot be conclusively determined a manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.An issue was identified during the investigation.The potential cause of the damage on the electrode and the spline cannot be established.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.Do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.Prior to removing or repositioning the catheter, use direct imaging guidance such as fluoroscopy to confirm that the spine assembly is not entangled with another catheter or with an anatomical structure.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: 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: 22683764
• Report Number: 2029046-2025-02503
• Device Sequence Number: 13129658
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: (01)10846835021127(11)250313(17)280312(10)31604895L
• 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

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: D160903
• Device Lot Number: 31604895L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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: 8.5F SHEATH, VIZ SMCURVE, SHORT.
• Patient Sex: Unknown