MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	NI75TCBH
Medical Device Problem Codes	Mechanical Jam (2983); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a deflection test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the navi-star¿ thermo-cool¿ electrophysiology catheter.A deflection test was performed following the bwi procedure and the device failed the test since it was only deflecting, but not relaxing.There were no anomalies found during the dissection that might contribute to the condition presented during the deflection test.An unrelated issue was found during the dissection.Unusual polyurethane (pu) residues on the puller wire lumen cavity were found.This is not a regular condition during the pu application.Although though this issue does not cause a mechanical failure/deflection issue, it is manufacturing related.This issue is considered an isolated and a unique incident, also considered improbable or unlikely to occur based on risk determination of the manufacturing environment.The customer also provided a video of the reported catheter condition to aid in the investigation.According to the video provided by the customer, the tip was observed semi-deflected with piston up.The customer complaint was also confirmed based on the video received.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
A patient underwent an atrioventricular reentrant tachycardia (avrt) procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified the deflection mechanism was stuck in a deflected position.It was initially reported by the customer that during the operation and the catheter was unable to deflect or relax completely.A second catheter was used to complete the operation.There was no adverse event reported on patient.The customer¿s initial reported deflection issue was assessed as not reportable since insufficient deflection or not relaxing completely (without being stuck in the deflected position) has a most likely consequence of an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On 17-feb-2022, bwi¿s pal revealed the visual inspection of the returned device found the deflection test failed.The device was only deflecting but not relaxing.The issue of deflection being stuck is considered to be an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product evaluation on 17-feb-2022 and reassessed it as mdr reportable.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13811512
• Report Number: 2029046-2022-00565
• Device Sequence Number: 4466991
• Product Code: OAD
• UDI-Device Identifier: 10846835008333
• UDI-Public: 10846835008333
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: 07/14/2024
• Device Model Number: NI75TCBH
• Device Catalogue Number: NI75TCBH
• Device Lot Number: 30607934M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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: DEF 7.5F TCNSTC,4P,B,252MM,HYP
• Patient Sex: Unknown