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

Catalog Number	D160906
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture was received for evaluation following johnson & johnson medtech's procedures.According to pictures provided by the customer, some fiber like material was observed in one of the splines of the catheter.However, no damaged or missing electrode was observed on the image.A manufacturing record evaluation was performed for the finished device number lot 31423355l and no internal action related to the complaint was found during the review.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.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).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with an octaray mapping catheter and the catheter was physically damaged.The octaray was in the right atrium through the sheath.The doctor felt an unusual resistance when pulling it out.He then noticed that one of the splines was damaged and that the distal electrode from that spline was gone.He passed a guide wired in the sheath and pulled it out of the patient to check it and flushed it without any abnormal feeling.After that, he put the dilator in the sheath (outside the patient) to access left atrium again but felt resistance.Once the dilator was seen outside the sheath tip, some kind of wiring from the damaged octaray spline was pushed out.There was no patient consequence.
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 cardiac ablation procedure with an octaray mapping catheter and the catheter was physically damaged.The octaray was in the right atrium through the sheath.The doctor felt an unusual resistance when pulling it out.He then noticed that one of the splines was damaged and that the distal electrode from that spline was gone.He passed a guide wired in the sheath and pulled it out of the patient to check it and flushed it without any abnormal feeling.After that, he put the dilator in the sheath (outside the patient) to access left atrium again but felt resistance.Once the dilator was seen outside the sheath tip, some kind of wiring from the damaged octaray spline was pushed out.There was no patient consequence.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection of the returned device was performed in accordance with j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.A microscopical inspection of the device was performed at the tip area and electrodes forty-fourth and forty-three were lifted and had foreign material attached.No other damage or anomalies were observed.No manufacturing deficiencies were found.A fourier transformed infrarred spectroscopy (ftir) study was requested for the foreign material and it was found that it was composed of polytetrafluoroethylene (ptfe) which could be related to the sheath used in the procedure as this material is used as an internal component of the shaft in the carto vizigo sheaths.The detachment of ptfe could be related to the damaged electrode on the octaray.A manufacturing record evaluation was performed for the finished device 31423355l, and no internal action was found during the review.The resistance, and electrode damaged issues were confirmed; however, the tip fully separated issue could not be confirmed, as no damage to the tip or spline was observed.The potential cause of the resistance issue could not be established conclusively.The foreign material, and electrode damage could be the consequence of the resistance issue described.The instructions for use contain the following recommendations: 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.The catheter is recommended for use with an 8.5 f 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 use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered.As part of the 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 electrode problem.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the foreign particles in electrode.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the reported issue of tip fully separated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21692437
• Report Number: 2029046-2025-00907
• Device Sequence Number: 13081725
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: (01)10846835021134(11)240814(17)250813(10)31423355L
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2025

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: 08/13/2025
• Device Catalogue Number: D160906
• Device Lot Number: 31423355L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 05/13/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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: UNK_SHEATH.
• Patient Sex: Unknown