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

Catalog Number D134801

Device Problems Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

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.E1.Initial reporter phone: (b)(6) (main) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-01204 for product code d134801 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2024-01205 for product code d134801 (thermocool® smart touch® sf bi-directional navigation catheter).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with two (2) thermocool® smart touch® sf bi-directional navigation catheters and the holes that were not irrigated during ablation.Char was found adhering to the tip of the first thermocool® smart touch® sf bi-directional navigation catheter (lot: 31215083l).When the catheter was flushed, it was pointed out there were holes with no irrigation flow, so it was replaced with another lot of thermocool® smart touch® sf bi-directional navigation catheter (lot: 31215001l).The procedure was continued.The tip of the ablation catheter was checked again while flushing.Since the irrigation was not flowing, (lot: 31215001l) was replaced with another lot of ablation catheter, and the procedure was continued.#1 catheter (lot: 31215083l) had issue at approximately 4 hours after the use of the catheter.#2 catheter (lot: 31215001l) had issue at approximately 90 minutes after the use of the catheter.There were no problems with irrigation during ablation, but there were holes that were not irrigated during flushing.No error was displayed on the irrigation pump.Heparinized normal saline was used.Patient was anticoagulated with activated clotting time (act) around 300.

Manufacturer Narrative

On 15-apr-2024, additional information was received indicating the setting of pre rf time and post rf time was pre 3s, post 3s.Settings included temperature cut off: 40, impedance: max.250o, no spike, min.50o.Respiration visitag module was used with the following settings: stability range: 3mm, stability time: 3sec., fot: 25%/3g, tag color: low 400, high 450, tag size: 2.In addition, concomitant products of "smartablate pump kit (japan)" and "smartablate gen.Kit (japan)" were provided.Please consider these replacements for the previously reported "unk_smartablate pump" and "unknown irrigation pump".On 23-apr-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with two (2) thermocool® smart touch® sf bi-directional navigation catheters and the holes that were not irrigated during ablation.Char was found adhering to the tip of the first thermocool® smart touch® sf bi-directional navigation catheter (lot: 31215083l).When the catheter was flushed, it was pointed out there were holes with no irrigation flow, so it was replaced with another lot of thermocool® smart touch® sf bi-directional navigation catheter (lot: 31215001l).The procedure was continued.The tip of the ablation catheter was checked again while flushing.Since the irrigation was not flowing, (lot: 31215001l) was replaced with another lot of ablation catheter, and the procedure was continued.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, temperature, impedance, and irrigation test of the returned device were performed following bwi procedures.Visual analysis revealed char in the tip of the device; however, the residues were lost during the decontamination process.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.Afterward, an irrigation test was performed and no obstructed holes were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Since char was observed in the decontamination lab, the irrigation and char issues reported by the customer were confirmed.Char can be the normal result of the ablation process.The irrigation issue reported could not be confirmed during the product investigation.The instructions for use (ifu) contain the following recommendations: when radiofrequency (rf) energy is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum, if present.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 19094167
• MDR Text Key: 340689740
• Report Number: 2029046-2024-01204
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 04/11/2024

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 Catalogue Number: D134801
• Device Lot Number: 31215083L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/15/2024; Not provided
• Supplement Dates FDA Received: 05/07/2024; 06/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2023
• 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: SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN); THMCL SMTCH SF BID, TC, D-D; UNKNOWN IRRIGATION PUMP; UNK_CARTO 3; UNK_PENTARAY; UNK_SMARTABLATE PUMP