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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tachycardia (2095)

Event Date 04/03/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an isvt procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a ventricular tachycardia requiring surgical intervention and prolonged hospitalization.It was reported that when vt was induced the patient's systolic blood pressure dropped to 50 mmhg systolic.When vt was terminated the pressure remained low, so the physician installed an impella device.The vt ablation procedure was continued.They also reported a significant hematoma at the catheter/impella insertion site, in the patient's groin.The patient was intubated and anesthesia was monitoring their status.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was procedure and patient condition related.The patient was induced on the vt and their blood pressure dropped after converting a sinus rhythm.Blood pressure did not improve and an impella was placed for pressure support.Patient improved during the procedure as far as pressure support goes, however, post procedure it was found that the patient had a severe damage to their femoral artery during upsizing the sheath for the impella.This lead to vascular surgery to repair the femoral artery.Patient required extended hospitalization because of the adverse event as even though the patient was stabilized, the patient was placed on hospice care due to her disease state and condition.It was also reported that the carto 3 system green back patch cable was physically damaged when moving patient quickly off the procedure table.This issue is not considered to be mdr reportable since it is highly detectable and the most likely harm is a procedure delay or cancellation.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because 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.Note: hematomas at the puncture site are associated with sheaths.The sheaths utilized at the hematoma site were a 5f sheath (st.Jude) and subsequently via exchange a 23f abiomed sheath.The hypotension is associated with the vt.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

On 27-apr-2023, additional information was received indicating the sheath used for ablation on the patients right was a 12fr sheath that accepted the vizigo.On the patients left there was a 5fr sheath that was upsized with the impella sheath system.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: 16829593
• MDR Text Key: 314162779
• Report Number: 2029046-2023-00909
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 23F ABIOMED SHEATH; CARTO 3 SYSTEM; ST. JUDE SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female