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

Catalog Number	D160902
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The biosense webster failure analysis lab received a returned box with a used device (octaray mapping catheter).There was sender identity.Multiple attempts have been made to obtain clarification to this device.However, no further information has been made available.In addition, a search was also performed by the biosense webster complaints handling unit and were also unable to identify a complaint associated with this product.Therefore, this complaint file was created for this extra product received.The biosense webster, inc.Product analysis lab evaluated this device and per the evaluation completion on 07-may-2024, there was one spline of the device bent and had damaged electrodes.The electrodes were observed dented and partially lifted; no internal components were exposed.Bwi became aware of damaged electrodes (bent and partially lifted) on 07-may-2024 and have assessed this returned condition as reportable.The awareness date on this returned condition is 07-may-2024.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).The device evaluation was completed on 07-may-2024.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed that one spline of the device was bent and had damage electrodes.The electrodes were observed dented and partially lifted; no internal components were exposed.No other issues were observed during the visual inspection.The device was connected to the carto 3 system, and it was recognized and visualized; however, an electrode was visualized black on the system due to and open circuit on the tip area.This issue could be related to the damage on the spline of the device.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 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.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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 ¿electrodes were observed dented and partially lifted¿.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿spline bent¿.-investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the biosense webster inc.Analysis finding of the ¿open circuit¿.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: 19463591
• Report Number: 2029046-2024-01815
• Device Sequence Number: 20826512
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• 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
• Report Date (Section B): 06/04/2024

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: 06/26/2024
• Device Catalogue Number: D160902
• Device Lot Number: 31101967L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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
• Patient Sex: Unknown