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

Model Number D132705

Device Problems Signal Artifact/Noise (1036); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a video was 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).

Event Description

It was reported that a patient underwent a non- ischemic ventricular tachycardia (isvt) - left ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a detachment of device issue occurred.It was reported that the catheter got stuck during retro aortic access around the mitral valve septally.It was impossible to remove it at first.Catheter was removed after 1hour and 45min fluoroscopy.Catheter broke physically during manipulation to remove it.No more signals in map 1-2.Surgery was delayed due to the reported event for 60 minutes.Action taken when event occurred was pushing, turning, pulling catheter with use of xr, echography intracardiac and help from other physicians.Procedure was successfully completed.There are no patient consequences.Medical intervention was echography intracardiac color after the event: result was okay.The adverse event occurred on (b)(6) 2023.It was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was the procedure and manipulation.Patient did not require extended hospitalization because of the adverse event.The damage did not result in wires being exposed nor in any lifted or sharp rings.Catheter was not pre-shaped.Sheath used was an agilis 8.5fr abbott.In the physician¿s opinion, the delay did not contribute to a death or a serious injury to the patient.Echography was used to check everything was okay and it was.(generator used was a ngen 22480205fc ¿ v2.) the medical device entrapment and bad partial ecg were assessed as not mdr reportable to the fda.The detachment of device issue is mdr reportable to the fda.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 20-mar-2023.The device evaluation was completed on 24-mar-2023.It was reported that a patient underwent a non- ischemic ventricular tachycardia (isvt) - left ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a detachment of device issue occurred.Device evaluation details: a video was received for evaluation following biosense webster's procedures.According to the video provided by the customer, reddish material, presumably blood, was observed inside the pebax.However, no external damages could be observed in the video that could be related with the condition reported.The customer complaint cannot be confirmed based on the video received.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, electrical and functional test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax due to a hole on the surface of the device.The tip was partially detached; however, no wires were exposed.A dimensional test was performed, and outer diameters of the device were found within specifications.An electrical test was performed and an open circuit was found on the tip area.A manufacturing record evaluation was performed for the finished device 30785430m number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.H6.Investigation findings code of "appropriate term/code not available" represents 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16549916
• MDR Text Key: 311592913
• Report Number: 2029046-2023-00540
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNK AGILIS 8.5FR ABBOTT SHEATH; UNK_NGEN RF GENERATOR