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

Catalog Number	D160901
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	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with an octaray mapping catheter for which biosense webster¿s product analysis lab (pal) identified a lifted electrode and a plastic fiber attached to the electrode.Initially, it was reported that at the end of the procedure, when they pulled out the octaray catheter, they noticed a plastic stringlike piece attached to the base of the splines.Unraveled like a sweater unraveled.They had no issues with the catheter during the procedure.No patient consequence reported.The catheter was brand new from biosense webster, inc.Box packaging.Additional information was received.Does not believe that there were wires exposed.Did not result in any lifted or sharp rings.The physician never mentioned any resistance.It was not known if the device was pre-shaped.The plastic stringlike piece issue was assessed as mdr reportable under the vizigo sheath reported under manufacturer report number 2029046-2026-00581.The biosense webster, inc.Product analysis lab received the octaray mapping catheter for evaluation and per the evaluation completion on 09-mar-2026, found a lifted electrode in one of the splines, blood residues and a plastic fiber attached to the same electrode.The returned conditions of the lifted electrode and a plastic fiber attached to the electrode are assessed as reportable under the octaray mapping catheter.
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j) for evaluation on 17-feb-2026.A visual inspection evaluation of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed a lifted electrode in one of the splines, blood residues and a plastic fiber was found attached to the same electrode.No other issues or anomalies were found during the analysis.Due to the plastic fiber, a fourier transform infrared spectroscopy (ftir) analysis was requested and the results indicate that the composition of the foreign material particle exhibits characteristic feature of a polyurethane-based material, plastic material used in the medical device industry.However, the source of the material remains unknown.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Based on the information currently available, a product issue was identified during the investigation of the sample received.The potential cause of the electrode lifted, blood residues and plastic fiber could be related to the handling of the device during the procedure; however, this can not be conclusively determined.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿lifted electrode¿.-investigation findings: environment problem identified (c15) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of ¿a plastic fiber attached to the same electrode¿.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).

• 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: 24776369
• Report Number: 2029046-2026-01097
• Device Sequence Number: 17658747
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: (01)10846835021141(11)251016(17)281015(10)31793000L
• Combination Product (Y/N): N
• 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): 04/01/2026

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: 31793000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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: OCTA,STD,48P,2-2-2-2-2,D-CURVE; UNK_NGEN RF GENERATOR; UNK_TRUPULSE GENERATOR
• Patient Sex: Unknown