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 Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 (b)(6) male (72 kgs) patient underwent a pulmonary vein isolation (pvi) paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Pvi followed by induction of atrioventricular nodal reentrant tachycardia (avnrt) were performed, then the patient became hypotensive and pericardial effusion was noted on intracardiac echocardiography (ice) imaging.The caller stated that during the induction of the avnrt, the thermocool® smart touch® sf bi-directional navigation catheter was advanced into the left ventricle (lv) and the max force reading seen at that location was 24 grams.Pericardiocentesis was performed with auto transfusion and fresh frozen plasma (ffp).The patient was then moved to the operating room to have an open-heart surgery.Patient¿s condition improved and was reported in stable condition.Extended hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.Per the physician, the patient might have abnormal tissue in the left ventricle (lv) and he recalled contact force (cf) was 40 in the lv at one point.Transseptal puncture was performed with a brk needle.The max wattage used was: left side (40w), right side (30w).The total ablation time was 25 mins, 13 seconds.The total fluid via the catheter was 1208ml.There was no evidence of steam pop during the ablation.Force dashboard and vector in use.The parameters for stability used with the visitag module were 3mm, 3 secs, 25%@3g.Surpoint was used as color option.No error messages were noted on the carto 3 system or smart ablate system.Since the event is life threatening and required surgical intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.The high force issue was assessed as not mdr reportable.The high force issue was highly detectable when occurring.The potential risk that it could cause or contribute to a death or serious injury was remote.

Manufacturer Narrative

Device evaluation was completed on 12/8/2020.It was reported that a 60-year-old male (72 kgs) patient underwent a pulmonary vein isolation (pvi) paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Pvi followed by induction of atrioventricular nodal reentrant tachycardia (avnrt) were performed, then the patient became hypotensive and pericardial effusion was noted on intracardiac echocardiography (ice) imaging.The caller stated that during the induction of the avnrt, the thermocool® smart touch® sf bi-directional navigation catheter was advanced into the left ventricle (lv) and the max force reading seen at that location was 24 grams.Pericardiocentesis was performed with auto transfusion and fresh frozen plasma (ffp).The patient was then moved to the operating room to have an open-heart surgery.Patient¿s condition improved and was reported in stable condition.Extended hospitalization was required.Per the physician, the patient might have abnormal tissue in the left ventricle (lv) and he recalled contact force (cf) was 40 in the lv at one point.The device was visually inspected and it and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal action was found during the review.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 10820449
• MDR Text Key: 216613007
• Report Number: 2029046-2020-01664
• 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
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30407515M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NON BWI-UNK BRAND BRK NEEDLE; UNK_MOBICATH; UNK_PENTARAY; UNK_SOUNDSTAR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 72