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

Model Number D132705

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a knotted catheter and medical device entrapment with excessive manipulation required issues occurred.During left ventricular vt mapping on a pvc case, the thermocool® smart touch¿ bi-directional navigation catheter got stuck in the anterior papillary muscle.We could verify images thanks to sound catheter and ice images, fluoroscopy system as well as carto system.Thermocool® smart touch¿ bi-directional navigation catheterwas inserted into agilis bidirectional sheath.Catheter was looped to access a septal position and got stuck while trying to go back to a basal septal position.Access was done by transseptal puncture.Surgery was delayed due to the reported event for 60 minutes.They tried to pull, to push, to turn, to deflect, to advance the sheath.No patient consequences were reported.Additional information was received.They asked another physician to come over (valve specialist) and he succeeded to give the right manipulation advice to remove catheter.They succeeded to remove it without complications and the delay did not contribute to a death or a serious injury to the patient.They put the patient under general anesthesia after this event because he was very stressed.They continued the procedure after that.No further delay.The curve of the catheter was not stuck in a deflected position and could be deflected as wanted.It was impossible to remove the catheter at first.No weird manipulation just stuck inside papillary muscle.They tried for one hour.Implying a lot more xray for patient and physician.Sheath information was agilis, 8,5fr abbott.There was no detachment of any component.The loop/tip became unknotted.The issue did not result in exposure of any internal catheter components or sharp edges.The event was assessed as mdr reportable for a knotted catheter issue and for a medical device entrapment with excessive manipulation required issue.

Manufacturer Narrative

No device has been received for analysis.Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.  video's were provided by the customer.Evaluation is still in progress.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.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).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a knotted catheter and medical device entrapment with excessive manipulation required issues occurred.The video investigation was completed on 21-dec-2022.Two videos were received for analysis showing ultrasound and ice images.Even when the videos are related to the reported event, they do not provide sufficient information related to a device failure mode, and no conclusion can be made.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed based on the videos received.The device has not been returned for analysis, and a root cause cannot be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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: THERMOCOOL® SMART TOUCH¿ BI-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: 16020340
• MDR Text Key: 308214290
• Report Number: 2029046-2022-03212
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30785430M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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: NON BWI-ABBOTT AGILIS BIDIRECTIONAL 8F SHEATH; NON BWI-FLUOROSCOPY SYSTEM; UNK_CARTO 3; UNK_SOUNDSTAR
• Patient Sex: Male