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

Model Number D134805

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

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Initial reporter phone: (b)(6).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 male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the patient suffered a thrombus and cerebrovascular accident (cva) requiring prolonged hospitalization.After the procedure was completed on (b)(6) 2022, the patient did not wake up from the sedation, and there was a finding that the right hand did not move.The patient was then urgently transferred to magnetic resonance imaging mri.No error codes.Impedance spikes were not detected in the procedure.The irrigation was functioning normally.Spontaneous respiration was not stable, and ablation was performed while contact was unstable.To perform pulmonary vein isolation (pvi), the frequency of ablation was higher than usual.The thermocool® smart touch® sf bi-directional navigation catheter was collected because the procedure had already been completed.At that time, blood was sticking to the tip of stsf, but because time had passed, it was not clear whether it was due to elapsed time or ablation.The status of stsf was not mentioned by the physician at the time of catheter removal.The subsequent course of the event was unknown because the physician was going to deal with the patient.As of (b)(6) 2022 the patient's left arm moved but the patient could not speak.Patient was in critical care unit (ccu).Action taken for cerebral infarction was unknown.The activated clotting time (act) during surgery was 250.However, postoperative aptt was within normal range.The physician commented that because it is persistent atrial fibrillation the cerebral infarction was caused by a thrombus that was present before surgery.It was unknown if it is related to stsf.It was unknown whether the thrombus adhered to the stsf or sheath after the surgery.The sheath used was a leftee and the transeptal needle was a nrg rf transseptal needle.Additional information was later received indicating the physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient outcome was reported as improved.The generator used in the case was a smartablate and service for the unit is not needed.It was unknown whether the thrombus was attached to the stsf or sheath.

Manufacturer Narrative

On 19-feb-2022, 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 male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the patient suffered a thrombus and cerebrovascular accident (cva) requiring prolonged hospitalization.After the procedure was completed on (b)(6) 2022, the patient did not wake up from the sedation, and there was a finding that the right hand did not move.The patient was then urgently transferred to magnetic resonance imaging mri.No error codes.Impedance spikes were not detected in the procedure.The irrigation was functioning normally.Spontaneous respiration was not stable, and ablation was performed while contact was unstable.To perform pulmonary vein isolation (pvi), the frequency of ablation was higher than usual.The thermocool® smart touch® sf bi-directional navigation catheter was collected because the procedure had already been completed.At that time, blood was sticking to the tip of stsf, but because time had passed, it was not clear whether it was due to elapsed time or ablation.The status of stsf was not mentioned by the physician at the time of catheter removal.The subsequent course of the event was unknown because the physician was going to deal with the patient.As of on (b)(6) 2022, the patient's left arm moved but the patient could not speak.Patient was in critical care unit (ccu).Action taken for cerebral infarction was unknown.Additional information was later received indicating the physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient outcome was reported as improved.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 an evaluation of all features of the device.Visual analysis of the returned product revealed that no damage or anomalies were observed on the device.Per the event, several tests were performed.The magnetic, temperature, and force features were tested and no issues were observed.In addition, the product was deflecting correctly.However, the catheter was not irrigating properly due to char residues on the tip.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.However, char was confirmed.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event.Investigation findings: problem due to thrombosis activation (c010604) / investigation conclusions: cause not established (d15) / component code: cautery tip (g01002) were selected as related to the char found on the device.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 (STSF
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13547145
• MDR Text Key: 290078345
• Report Number: 2029046-2022-00324
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30648136L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/19/2022; 04/18/2022
• Supplement Dates FDA Received: 03/15/2022; 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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: LEFTEE SHEATH.; NRG RF TRANSSEPTAL NEEDLE.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male