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

Model Number D134805

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

Patient Problems Stroke/CVA (1770); Thrombosis (2100); No Code Available (3191)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

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 was performed for the finished device lot# 30320622m, and no internal actions 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.Initial reporter phone: (b)(6).(b)(4).

Event Description

It was reported that a patient (patient demographics and medical history were not provided) underwent paroxysmal atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered thrombosis and cerebrovascular accident (cva) requiring thrombectomy catheterization.Pulmonary vein isolation (pvi), cavotricuspid isthmus (cti), and superior vena cava (svc) isolation were performed for patients with paroxysmal atrial fibrillation.During pvi the impedance increased and when the thermocool® smart touch® sf bi-directional navigation catheter was examined it was found to be burnt.The physician judged that there was no problem and did not change the catheter.Catheter was not replaced during the case, and the procedure was continued by removing the charred part.The procedure was continued and the case was completed.The patient returned to the ward without any problem after the end of the case, but the patient's condition suddenly changed at night.Left upper limb and left nerve palsy were confirmed.Magnetic resonance imaging (mri) confirmed acute phase cerebral infarction in the right middle cerebral artery (mca) territory.Due to the influence of covid-19, we were not able to attend and did not receive our report.Confirmed the event during later visit.On the same day, an emergency catheterization was performed at mie university hospital.The patient's subsequent course was favorable, and the patient was currently hospitalized for rehabilitation at sakakibara-hot spring hospital.Because transesophageal echocardiography was not performed due to the influence of covid-19, it was unknown when the thrombus was formed before or during the case.Due to the attendance regulations imposed by covid-19, the sales representative ("patient") was unable to attend the hospital.When they visited the hospital today, they heard about this event.The physician¿s commented that impedance increased in the patient, and the catheter was found to be charred, but it was judged that there was no problem as long as the catheter was removed, and the procedure was continued (no replacement of catheter).Opinion that it may not be related to the product itself.When the sales representative asked the physician about the relationship between catheter charring and cerebral infarction, the physician answered that charring was confirmed but there was no problem with patient condition after wiping it, and there was no abnormal sensation at hand.Transesophageal echocardiography was also not performed, so we could not decide whether the catheter was the cause or not.

Manufacturer Narrative

During an internal review, it was noted on 10/27/2020 that there is a correction to the 3500a follow-up #1 as in error d11.Concomitant medical products and therapy dates was not populated with the smartablate generator that was used in the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on (b)(6) /2020.The patient is a 87 year old female (48kg).The physician did not declare [the event] due to the product, but did not state the cause.The patient¿s condition had improved.The smartablate generator was used in the procedure.Therefore, a2.Patient age at the time of event; a2.Age unit; a3.Sex; a4.Weight of the patient; a4.Weight unit and d11.Concomitant medical products and therapy dates.Additional information was received on (b)(6) 2020.There was no abnormality in mobicath.No association between char formation and mobicath has been reported.Physician did not mentioned the relationship mobicath and cerebral infarction.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10360259
• MDR Text Key: 201884004
• Report Number: 2029046-2020-00989
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30320622M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK; MOBICATH SMC GUIDING SHEATH; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO SMS 8F CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 48