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

Model Number D134703

Device Problems Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and functional test of the returned device.The device was inspected, and revealed a hole in the pebax, and it was confirmed by sem.Char was found in the returned thermocool® smart touch® sf uni-directional navigation catheter.No other physical damage was found.Generator and cool flow testing was performed in accordance with bwi procedures.The returned sample was connected to the generator and cool flow, and temperature/impedance and flow values were observed within specifications.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The evaluation determined that char is a physical phenomenon of rf.The instructions for use contain the following instruction: in the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn, and the tip electrode inspected for coagulum before rf current is reapplied.Remove any coagulum with a sterile gauze pad dampened with sterile saline.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.Additionally, the customer provided photos of the catheter condition.According to pictures provided by the customer, char was observed on the dome and reddish material was observed inside the pebax.However, the photo did not provide sufficient information related to the reported event of steam pop and the high-temperature issue, therefore no result can be obtained from it.Explanation of codes: investigation findings: problem due to thrombosis activation (c010604) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the char issue.Investigation findings: mechanical problems identified (c07) / investigation conclusions: cause not established (d15) / component code: membrane (g04088) were selected as related to the hole in the pebax.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) as related to the steam pop and temperature issues.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) persistent with a thermocool® smart touch® sf uni-directional navigation catheter and biosense webster¿s product analysis lab identified a hole in the pebax during product evaluation.It was initially reported by the customer that they had three steam pops in the right atrium and three steam pops in the left atrium.The caller also stated the force readings were 3,7, and 10 grams.The patient was stable.The caller stated there was some char on the tip electrode of the catheter.The caller did suggest to the physician to switch the catheter but they continued to complete the case.Additional information was later received indicating the patient did not exhibited any neurological symptoms since the completion of the case.The temperature was reported to be higher than normal @ 24-25 degrees celsius.The smartablate generator parameters were in power control mode and temperature cut off @ 40 degrees.The noted temperature, impedance and power was power @ 47w in la 45w in ra, impedance around 100-115 ohms, temperature @ 24-25 degrees.The patient was anticoagulated with 350 maintained throughout procedure.Half-normal, heparinized saline was used.Duration of ablation was greater than 60-120 seconds.Contact force was not greater than 25 or 40 grams.Force below 20g.Irrigation was @ 45 & 47w, 15 ml/min used for thermocool® smart touch® sf (stsf) catheters.The correct catheter settings were set on the smartablate generator.The smartablate pump was switching from low¿ to ¿high¿ flow during ablation.Visitag module used respiration gating, stability @ 3mm, time @ 5seconds with time color option.Temperature did not exceed cut off settings.There was no visible physical damage to the catheter upon inspection.The customer¿s reported issue of steam pop is not considered to be an mdr reportable issue since steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.The high temperature is not mdr reportable since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The issue of char is not mdr reportable since char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.In addition, biosense webster inc.Has reassessed the reportability of char-related events and has determined that these events, which were previously reported as malfunctions, are ¿not reportable.¿ on 7-jun-2022, bwi¿s pal revealed that a visual inspection of the returned device found a reddish material inside the pebax and a hole was also found and then confirmed by scanning electron microscope (sem).

• 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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15156649
• MDR Text Key: 304902667
• Report Number: 2029046-2022-01779
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• 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: 08/03/2022

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 Expiration Date: 02/23/2023
• Device Model Number: D134703
• Device Catalogue Number: D134703
• Device Lot Number: 30721381L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• 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: CARTO 3 SYSTEM; MERIT HEARTSPAN FIXED CURVE TRANSSEPTAL SHEATH; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US