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

Model Number D134801

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Cardiac Tamponade (2226)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental 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 patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, pacing from the right ventricle (rv) apex was not captured by the rv catheter, and the catheter was placed in the right ventricle outflow tract (rvot).Left pulmonary vein isolation (lpvi) was then completed, and right pulmonary vein (rpv) ablation was started.At that point, the patient¿s blood pressure dropped, and the patient became bradycardic.Cardiac tamponade was confirmed via echocardiography.The remainder of the procedure was aborted, and pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.Blood was transfused to the patient as well.The patient was then moved to the cardiac care unit (ccu).It is unknown if extended hospitalization was required as a result of the adverse event.Patient¿s outcome is unknown.From the echocardiography image findings, the rv catheter placed in the rvot appears to be the cause of the adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this event is life threatening and required medical intervention 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.

Manufacturer Narrative

On (b)(6) 2020, biosensen webster inc.Received additional information about the patient and event.It was reported the patient was a 77-year-old female patient (weighing 55.2kg).Patient had recovered from the issue.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.There was no evidence of steam pop during the ablation.No bwi product malfunctions nor error messages were reported.Device investigation details: 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 30380164m number, and no internal action 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.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 8-oct-2021, biosense webster inc.Received additional information about the patient.It was reported the patient had a medical history of hypertension (systolic blood pressure = 140 mmhg) and diabetes mellitus.It was also reported the patient experienced an occurrence of atrial fibrillation on (b)(6) 2021 and remission from the occurrence of atrial fibrillation on (b)(6) 2021.The condition of atrial fibrillation was assessed as serious, severe, possibly related to the device and related to the procedure, although atrial fibrillation was the patient¿s original condition being treated as part of the study.Since the report of atrial fibrillation is considered to be a reoccurrence of pre-existing condition, this will not be considered an mdr reportable adverse event.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was previously confirmed this complaint is from a post market study (non-bwi sponsored study).This information was inadvertently omitted from supplemental (follow-up) medwatch report # 1.

• 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: 10486610
• MDR Text Key: 209624593
• Report Number: 2029046-2020-01150
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30380164M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 55