MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D132704
Medical Device Problem Codes	Positioning Failure (1158); Entrapment of Device (1212); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.E1.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
It was reported that a patient underwent a premature ventricular contraction ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the catheter it got stuck in the aorta.When bringing up the st via the artery to the aorta, it was not able to bend the catheter as usual.Because of the unusual manipulation of the catheter it got stuck in the aorta.The catheter had such a bad curve resulting it needed to get out by using specialized equipment.Even through manipulation or not it should not be able to bend like that.There was no patient consequence.A new catheter was used and issue was solved.
Additional Manufacturer Narrative
On 6-mar-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a premature ventricular contraction ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and the catheter it got stuck in the aorta.When bringing up the st via the artery to the aorta, it was not able to bend the catheter as usual.Because of the unusual manipulation of the catheter it got stuck in the aorta.The catheter had such a bad curve resulting it needed to get out by using specialized equipment.Even through manipulation or not it should not be able to bend like that.There was no patient consequence.A new catheter was used and issue was solved.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual, x-ray and dimensional inspections of the returned device were performed in accordance with bwi procedures.Visual analysis revealed several bents in the shaft and tip area, additionally, the shaft was cut close to the handle area.A dimensional inspection was performed, and it was under specifications.Due to the cut condition, the deflection test could not be performed however, the deflection mechanism was observed under the x ray machine and no anomalies were observed.A manufacturing record evaluation was performed for the finished device 31124231m, and no internal action was found during the review.Even when the deflection mechanism was unable to test due to the cut condition, the observed bents along the shaft and tip could be related to the issues reported by the customer therefore, customer complaint was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) and rod/shaft (g04112) were selected as related to the bents in the shaft and tip area.Investigation findings: no findings available (c20) / investigation conclusions: cause not established (d15) were selected as related to the customer's reported deflection issue since the issue could not be evaluated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 18593130
• Report Number: 2029046-2024-00317
• Device Sequence Number: 18171969
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P030031/S053
• 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,Followup,Followup
• Report Date (Section B): 01/28/2024

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: 08/03/2026
• Device Catalogue Number: D132704
• Device Lot Number: 31124231M
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 03/14/2024
• Initial Report FDA Received Date: 01/28/2024
• Supplement Report FDA Received Date: 03/08/2024; 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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