MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 11/14/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an afib ¿ paroxysmal ablation procedure with a smart touch thermocool surround flow.It was reported that they launched the qdot in the clinic with the ngen recently but it seems like there is a hardware or software issue.They didn't have any coloring for the sensor of the micro electrodes on catheter view tools bar.They turned off and rebooted the workstation, the piu (patient interface unit) and the ngen generator at the same time and it solved the issue.It was first grey, they get the feedback from the sensors and it turned blue.When they started mapping, they also had several distortions on pentaray catheter.The error on the pentaray catheter was a "severe magnetic distortion" error message.They tried to change the catheter cable, they checked everything around the location pad and the fluoroscopy, but nothing solved the issue.They had to change the catheter itself to solve the issue.Also, when they started with the new pentaray mapping, they couldn't have the respiration gating with the qdot as ablation catheter.It was the same with pentaray.They tried the respiration gating with qdot as ablation catheter, it didn't work several times.They switched to pentaray and had the same issue several times.The patient was breathing normally, so nothing external could have cause this issue to happen.They tried to put the catheter in the vein, also in the left atrium, but still couldn't help to get the respiration gating.They changed to the ctss catheter and could get the respiration gating at the beginning.However, the patient moved which result to the same issue again.They had to click on "learn new" and couldn't take the respiration gating anymore.Please note that they tried again with all catheters (ctss, qdot, pentaray, and vizigo) but nothing helped.The case has been aborted, as the map was not precise.They couldn't map.No patient consequences.1 hour delay reported.Please note that those are recurring issues.The caller isn't sure if the issue where those issue are coming from carto or ngen.The adverse event occurred on (b)(6) 2022.The adverse event was discovered during the procedure physician¿s opinion on the cause of this adverse event was bwi product malfunction: bwi product malfunction or software problem related to the carto system.Because when they changed the catheters, some of these issues related to the catheter has been solved.Therefore, the catheter was defect.There were no adverse event on the patient, only the catheters were probably defect and no residual effects.Patient did not require extended hospitalization because of the adverse event.Patient age at the time of event or date of birth (not available) not young but probably older than 55.Patient gender: male.Generator information- ngen generator with the serial number of: (b)(4), version: 2.0.27.61.Thermocool® smarttouch® sf catheter was used.All of the force features (graph, dashboard, vector and visitag) were used but they didn¿t get through the ablation in this case.They only got the features, but they didn¿t ablate.Only by set up: force and index (ablation index) parameters was used for the visitag module, but they didn¿t get through ablation process.Color options used prospectively was tag index (force, time and power) normally but they didn¿t get through the ablation process.Patient was under local anesthesia.Transseptal puncture performed prior to the case cancellation.The cancelation of the procedure did not contribute to a death or a serious injury to the patient.Nothing has happened to the patient.He was completely in a good condition.The cancellation was because they couldn¿t get the correct end respiration on the accuresp, neither with pentaray nor with qdot and stsf then actually it leads to not a correct map and there were a lot of errors from the catheters came out as explained in the complaints.But there were no circumstances on the patient, and he was on a good condition during and after the procedure.Patient did not require extended hospitalization due to a medical condition caused by procedure cancellation.It is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.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: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 15956923
• MDR Text Key: 305241876
• Report Number: 2029046-2022-03087
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO VISITAG MODULE; NGEN GENERATOR; PENTARAY CATHETER; QDOT MICRO; VIZIGO SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male