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

Model Number D134701

Device Problems Signal Artifact/Noise (1036); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

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 30837369l and no internal actions 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the electrode was damaged without foreign material with sharp/rough edges.The thermocool® smart touch® sf uni-directional navigation catheter would not advance through the vizigo sheath.When the ablation catheter was then used after attempting to go through the vizigo sheath, the signals were noisy.The catheter was replaced but was still unable to be advanced through the vizigo sheath.The sheath was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.Additional information was received on 14-sep-2022.The resistance they were having with the sheath was when they were trying to put the catheter into the sheath.There was no physical damage on sheath/dilator that could be seen externally.There was no occlusion when irrigating the sheath.The sheath felt partially blocked, catheter could only be inserted with extreme force, which damaged the catheter.The dilator was still partially able to be moved through the sheath.The dilator/catheter were not stuck in the sheath.The signal interference (noise) was observed when attempting to place the ablation catheter into vizigo sheath which damaged the sensors on the ablation catheter causing noise on the distal 1-2 electrodes.Noise was observed on the recording system and carto.The physician had an intact ecg signal available to monitor patient heart rhythm.Nothing was wrong with the ecg¿s.The noise was noticed once the catheter was placed into the heart without the sheath, but could be noticed both inside and outside of the patient body.The resistance with sheath issue was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.The noise issue was assessed as not mdr reportable.The risk to the patient was low.Requested clarification on the additional information received stating the sensors were damaged on the ablation catheter and damaged the catheter.However, no further information had been made available.With the information available, this issue was assessed as not mdr reportable for tip/ spline bent/tip twisted.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on 28-sep-2022.The metal on the tip of the catheter appeared distorted and bent.It seems as though the distal electrode was crushed.The additional information received on 28-sep-2022 was assessed as mdr reportable for electrode damage without foreign material with sharp/rough edges.The awareness date for this reportable issue is 28-sep-2022.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15678079
• MDR Text Key: 307110005
• Report Number: 2029046-2022-02651
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2022

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
• Device Operator: Health Professional
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30837369L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM; UNKNOWN BRAND SHEATH; UNK_CARTO 3