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 Thrombosis/Thrombus (4440)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 a male patient ((b)(6) year old, (b)(6) lbs) underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered thrombosis requiring no intervention.It was reported that the patient developed a clot in the anterior sulcus in left atrium away from ablation lines.After mapping and before ablation the patient was cardioverted and then ablation was begun in the left atrium.After about an hour into the procedure the patient went into atrial flutter and then the clot was identified on the atrial wall using the soundstar catheter that was in the left atrium.The patient was cardioverted again and now the clot was not seen in the left atrium anymore.An aortogram was performed and no clot was seen in the patient all the way to the iliac artery.The ablation procedure was then continued.The event was discovered after the use of biosense webster products.The physician considers patient condition as the cause of the adverse event.The event did not require medical intervention and the patient had fully recovered.The patient¿s hospitalization was extended overnight of observation.The patient was anticoagulated for the entire procedure, checked every 30 minutes with activated clotting time (act) over 300 maintained.There were no error messages or product issues observed by the physician.The generator was set to power control mode with 45w and 60 seconds.There were no lesions longer than 60 seconds and contact force was not over 25 grams.The irrigation flow settings were not outside of those prescribed, the pre-ablation high was 2 sec.Heparinized normal saline was used.The visitag stability settings were 3mm lesions.25% for 3 seconds, minimum 3 grams, 2mm spacing.Surpoint color options were used.The patient had not exhibited any neurological symptoms since the procedure was completed.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 10945584
• MDR Text Key: 219511380
• Report Number: 2029046-2020-01862
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• 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: 11/05/2020
• 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: CARTO 3 SYSTEM; UNKNOWN BRAND GENERATOR; UNK_SOUNDSTAR
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 62 YR