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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 female patient (b)(6)year old underwent cardiac ablation procedure for paroxysmal atrial fibrillation with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring no intervention.The patient's blood pressure dropped during left atrial posterior wall ablation.Intracardiac echo (ice) imaging was then used to visualize the heart, and a pericardial effusion was seen.A stat echocardiogram was ordered and performed.No pericardiocentesis was performed.The procedure was then aborted.The patient is stable at this time.Patient was admitted overnight.Ablation parameters were used as follows: max wattage: 35w, total number of lesions: approx.100, total fluid to the patient: 700ml.Transseptal puncture was performed with a brk needle.Agilis sheath used.No evidence of a steam pop was noted.Standard flow settings were used for 8/15ml.Force visualized by graph, dashboard, vector and visitag.Visitags were colored by tag index.3mm, 3secs, force 25% of the time at 3g.The event was noted during use of biosense webster ablation catheter.No intervention was required and the patient fully recovered.The extended stay was not related to the adverse event.She stayed over the weekend due to needing a pacemaker.The need for pacemaker was unrelated to effusion.There were no error messages on biosense webster equipment during the procedure.Since a drop in patient¿s blood pressure was observed the event is conservatively coded as cardiac tamponade.The procedure was aborted due to the adverse event.Since this event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.

Manufacturer Narrative

On 12/18/2020, 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).

Manufacturer Narrative

On 1/11/2021, the product investigation was completed.It was reported that a female patient (78 year old) underwent cardiac ablation procedure for paroxysmal atrial fibrillation with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring no intervention.The patient's blood pressure dropped during left atrial posterior wall ablation.Intracardiac echo (ice) imaging was then used to visualize the heart, and a pericardial effusion was seen.A stat echocardiogram was ordered and performed.No pericardiocentesis was performed.The procedure was then aborted.The patient is stable at this time.Patient was admitted overnight.Ablation parameters were used as follows: max wattage: 35w, total number of lesions: approx.100, total fluid to the patient: 700ml.Transseptal puncture was performed with a brk needle.Agilis sheath used.No evidence of a steam pop was noted.Standard flow settings were used for 8/15ml.Force visualized by graph, dashboard, vector and visitag.Visitags were colored by tag index.3mm, 3secs, force 25% of the time at 3g.The event was noted during use of biosense webster ablation catheter.No intervention was required and the patient fully recovered.The extended stay was not related to the adverse event.She stayed over the weekend due to needing a pacemaker.The need for pacemaker was unrelated to effusion.There were no error messages on biosense webster equipment during the procedure.Device evaluation details: the device was visually inspected 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 for the finished device 30420050m number, and no internal actions related to the reported complaint condition were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) 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: 10981880
• MDR Text Key: 220704520
• Report Number: 2029046-2020-01910
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30420050M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILIS SHEATH; BRK TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; PENTARAY NAV; SOUNDSTAR ECO; AGILIS SHEATH; BRK TRANSSEPTAL NEEDLE; CARTO 3 SYSTEM; PENTARAY NAV; SOUNDSTAR ECO
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR