MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NR7TCSIY
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6) 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 a navistar® rmt thermocool® electrophysiology catheter.When using the device in the patient by right route, there were no issues.However, when the medical team tried to go to left arterial route, the anatomical difficulties of the patient presented an issue.The physician observed the damage after the catheter was inserted, when he felt that the catheter was not responding as usual during the manipulation (it was an aortic femoral access, the resistance was due to the unusual anatomy of the descending aorta that required a lot of manipulation of the catheter to go through).The physician removed the probe from the patient and discovered that the device was broken.The sheath was broken, and there was an unusual angle on the catheter's shaft.There were no exposed wires or broken/lifted rings.The device was replaced with another.The procedure continued.No patient consequences were reported.
Additional Manufacturer Narrative
On 4-apr-2024, the product investigation was completed as the device was not returned for analysis.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31141333m and no internal action related to the complaint was found during the review.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
On 16-may-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a cardiac ablation procedure with a navistar® rmt thermocool® electrophysiology catheter.When using the device in the patient by right route, there were no issues.However, when the medical team tried to go to left arterial route, the anatomical difficulties of the patient presented an issue.The physician observed the damage after the catheter was inserted, when he felt that the catheter was not responding as usual during the manipulation (it was an aortic femoral access, the resistance was due to the unusual anatomy of the descending aorta that required a lot of manipulation of the catheter to go through).The physician removed the probe from the patient and discovered that the device was broken.The sheath was broken, and there was an unusual angle on the catheter's shaft.There were no exposed wires or broken/lifted rings.The device was replaced with another.The procedure continued.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection was performed following bwi procedures.Visual inspection was performed, and the tip was observed broken, leaving internal components exposed.During the investigation, evidence of proper manufacturing assembly was observed, once the transition was correctly assembled.A manufacturing record evaluation was performed for the finished device number lot 31141333m and no internal action related to the complaint was found during the review.The broken issue reported by the customer was confirmed.The potential cause of the damage could be related to the manipulation of the device during the procedure, however, this can not be conclusively determined.The instructions for use contain (ifu) the following warning and precaution: do not scrub or twist the distal tip electrode during cleaning.Catheter advancement should be done under fluoroscopic guidance.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.Do not insert or withdraw the catheter without placing the catheter tip in neutral position.When cleaning the tip electrode, handle the soft flexible segments with care and be careful not to twist the tip electrode with respect to the catheter shaft because twisting may damage the tip electrode bond and loosen the tip electrode.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.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: NAVISTAR® RMT THERMOCOOL® 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18973169
• Report Number: 2029046-2024-01014
• Device Sequence Number: 6299572
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024

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 Catalogue Number: NR7TCSIY
• Device Lot Number: 31141333M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/04/2024; 05/16/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/25/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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