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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30719877l, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cerebrovascular accident, thrombosis requiring surgical intervention and prolonged hospitalization.After the procedure was ended, hemiparesis of the right side of the patient was found.A mri and cerebral angiography were performed and revealed a cerebral infarction.There was no finding of char in the ablation procedure.Irrigation settings were high volume irrigation flow time: pre 1sec, post 5 sec.It was unknown where the char attached to the stsf.The thrombus was removed, but some remained, and the patient continued to be hospitalized.The patient was hemiparetic and unable to talk.The physician¿s opinion was after the ablation procedure completed, the physician didn't check the catheter whether char found on the ablation catheter.But the physician thought char might have occurred on the ablation catheter.The patient outcome is the patient received thrombectomy, but there was residual thrombus and hemiplegia remained: the patient couldn't even talk afterwards.The patient require extended hospitalization because of the adverse event.Extension of hospitalization due to hemiplegia associated with cerebral infarction.The generator used in the case was smartablate.Thrombus/clot is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15011102
• MDR Text Key: 295861549
• Report Number: 2029046-2022-01612
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30719877L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• 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; PENTARAY NAV; SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention