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

Catalog Number	D160906
Medical Device Problem Codes	Signal Artifact/Noise (1036); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j) for evaluation on 28-apr-2025.A visual inspection evaluation and electrical test of the returned device was performed following j&j medtech procedures.Visual inspection of the returned device revealed bent marks in one spline.A microscopic inspection shows a lifted electrode without wires exposed.The device was connected to the carto 3 system and no noise issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal action were identified.The spline bent condition reported by the customer was confirmed.The potential cause of the bent marks and lifted electrode could be related to the manipulation of the device before the procedure; however this can not be conclusively determined.The noise issue could not be confirmed.The catheter instructions for use (ifu) contain the following recommendations: excessive bending or kinking of the catheter shaft or spines may damage lead wires and cause loss of electrode function.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were elected as related to the customer¿s reported ¿a kinked spline ¿ issue.In addition, biosense webster inc.Analysis finding of the ¿bent marks in one spline¿.Investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿a kinked spline¿ issue.In addition, biosense webster inc.Analysis finding of the ¿lifted electrode¿.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿noise on the d spline¿ issue.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a redo atrial fibrillation / redo atrial flutter - left-sided procedure with an octaray mapping catheter for which biosense webster¿s product analysis lab (pal) identified a lifted electrode.It was reported that there was noise on the d spline of the catheter displayed on the carto 3 system and the recording system.The physician noticed a kinked spline on the catheter before advancing the catheter into the body.The catheter connections were reseated from both ends without resolution.The catheter was replaced and the issue was resolved.The procedure continued with no further issues.The ngen system was used for ablation.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 30-apr-2025, observed bent marks in one spline.A microscopic inspection showed a lifted electrode without wires exposed.The event was originally considered non-reportable, however, bwi became aware of a lifted electrode on 30-apr-2025 and have assessed this returned condition as reportable.

• 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: 22075031
• Report Number: 2029046-2025-01677
• Device Sequence Number: 18318393
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: (01)10846835021134(11)241211(17)271210(10)31527154L
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: D160906
• Device Lot Number: 31527154L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NGEN SYSTEM; UNK RECORDING SYSTEM; UNK_CARTO 3
• Patient Sex: Unknown