MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV DS; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BN7TCFJ8L
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
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.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 an atrial flutter (afl) ablation procedure with a ez steer nav ds and the catheter appeared bent under flouroscopy.The physician removed it and confirmed that it was bent at the tip.They replaced it to continue the case.No adverse patient consequence was reported.On 17-jul-2024, additional information was received which indicated that there was a small part of the wire that was exposed.With the additional information, the event is now considered mdr reportable with an awareness date of 17-jul-2024.There were no resistance nor difficulty during insertion and removal.It was noticed on fluoro that the tip was not straight after a few lesions had been placed and then removed.The damage was distal to the proximal electrodes.The catheter was not pre-shaped.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a ez steer nav ds and the catheter appeared bent under flouroscopy.The physician removed it and confirmed that it was bent at the tip.They replaced it to continue the case.No adverse patient consequence was reported.On 17-jul-2024, additional information was received which indicated that there was a small part of the wire that was exposed.With the additional information, the event is now considered mdr reportable with an awareness date of 17-jul-2024.There were no resistance nor difficulty during insertion and removal.It was noticed on fluoro that the tip was not straight after a few lesions had been placed and then removed.The damage was distal to the proximal electrodes.The catheter was not pre-shaped.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed a bent mark in the tip area.No internal components exposed were observed.The anchor window located in the tip is part of the catheter designed and no internal components were exposed.A manufacturing record evaluation was performed for the finished device 30941192m number, and no internal actions related to the reported complaint condition were identified.The bent condition reported by the customer was confirmed.The potential cause of the bent condition could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The internal components exposed could not be confirmed during the analysis.The catheter instructions for use (ifu) contain the following recommendations: do not scrub or twist the tip electrode because damage may cause catheter failure or patient injury.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Correction to the initial report: corrected full udi has been populated to field d4.Primary udi number.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: EZ STEER NAV DS
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 19889177
• Report Number: 2029046-2024-02580
• Device Sequence Number: 7778425
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: (01)10846835003048(17)251115(10)30941192M
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 11/15/2025
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 30941192M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• 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: SR0 SHEATH; UNK_NGEN RF GENERATOR
• Patient Sex: Unknown