MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's reference: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure and a blood clot was noticed on intracardiac echo, attached to the shaft of the lasso® nav eco variable catheter when it was in the left atrium.The physician advanced a long sheath along the lasso® nav eco variable catheter shaft to the point of the clot, then applied negative pressure with a syringe, aspirating as the sheath and lasso® nav eco variable catheter were removed simultaneously across the septum into the right atrium.When both products were removed from the patient¿s body, no blood clot found in either the sheath or the lasso® nav eco variable catheter.It was also confirmed that there was no thrombus observed on intracardiac echo in the left or right atrium.The patient was transferred to the intensive care unit (icu) for monitoring.Patient¿s outcome is unknown; however, post-procedure, the patient was immediately responsive and did not present stroke symptoms.The physician did not provide a causality opinion, although he never mentioned it was related to a biosense webster, inc.Product malfunction.There were no issues related to temperature or flow.The system had brief 6150 error but that was resolved by raising fluoroscopy, the machine was too close to chest.The power was at 50 watts and the impedance value looked normal and was monitored.The patient received anticoagulant (unspecified) during the case, with an activated clotting time (act) at high 200s.The duration of ablation used was 5 seconds maximum.Occasionally, there were high contact readings above 40 grams, none for extended period.The color option used prospectively was time.The issue of high force was assessed as a not reportable event as it is highly detectable.The potential risk that it could cause or contribute to a death or serious injury is remote.Since this adverse event "thrombosis" required medical or surgical intervention to preclude 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¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8773987
• MDR Text Key: 150540704
• Report Number: 2029046-2019-03394
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D133600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2019
• 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
• Patient Outcome(s): Life Threatening