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

Model Number D134805

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip issue occurred.It was reported that the catheter tip was broken during the procedure.The cable was replaced but the issue was not resolved.The catheter was replaced, and the issue was resolved, and the procedure was successfully completed without delay.There was no patient consequence.The damage did not result in wires being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue found was very close to the distal end of the catheter.The catheter was not pre-shaped.

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 20-oct-2021.It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip issue occurred.It was reported that the catheter tip was broken during the procedure.The cable was replaced but the issue was not resolved.The catheter was replaced, and the issue was resolved, and the procedure was successfully completed without delay.There was no patient consequence.The damage did not result in wires being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue found was very close to the distal end of the catheter.The catheter was not pre-shaped.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi then conducted visual inspection and deflection evaluation of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Deflection testing was performed, in accordance with bwi procedures and the device did not deflect.Afterwards, the catheter was dissected on the handle area and the puller wire was found detached from the brass ferrule causing the deflection issue.A manufacturing record evaluation was performed for the finished device 30571378l number, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the as the device tip was found in good conditions.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the broken tip issue.Investigation findings: mechanical problem identified (c07)/ investigation conclusions: cause not established (d15) / component code: clamp (g0405203) were selected as related to the brass ferrule issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) during an internal review on (b)(6)2021, it has been determined that since the damage did not result in wires being exposed nor were there any lifted or sharp rings, the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.As such, this event has been reassessed and is no longer considered to be mdr reportable against any bwi devices.The h6.Medical device problem code has been updated.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12511372
• MDR Text Key: 272659947
• Report Number: 2029046-2021-01607
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN AGILIS SHEATH; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN AGILIS SHEATH; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER