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

Model Number D134804

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30258732m number, and no internal action related to the complaint was found during the review.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and cardiac tamponade occurred requiring pericardiocentesis.It was reported that during mapping for idiopathic ventricular tachycardia ablation in the right ventricular outflow tract (rvot) region in a patient with compact constitution, a small pericardial effusion was discovered with ultrasound.The effusion was assessed as ¿too small¿ to require drainage.The pericardial effusion was confirmed by ultrasound and comparing the image to the one taken at the beginning of the case (when no effusion was present).A few minutes later the physician attempted ablation, but the generator would not allow the burning since there was a temperature sensor error displayed on the remote, and no temperature was displayed for the catheter.There was also no impedance reading.The cable was replaced without resolution.At this time the effusion increased, and it was decided to perform pericardiocentesis.An unspecified amount of fluid was removed.After drainage and intubating patient, the patient was reported to be in stable condition.The catheter was then replaced, and procedure continued.The physician commented that since we could not come ablation, he did not want to continue using the ablator because he was not sure if there was a force error along with the no temperature (¿ablation¿) error.The patient remained intubated overnight and was reported to make full recovery.Transseptal puncture was performed with an unknown transseptal needle, however, no ablation was performed prior to discovery of the effusion.The carto 3 system was operating per specs and was not responsible for the product issue.The catheter has been determined to be the root cause of the complaint reported.After the catheter was switched the irrigation settings were as prescribed on normal (low) flow during mapping.Visitag was used with the following settings: respiration adjustment, 2mm, min time = 3s, fot 50%, min force 3g.Size 2mm.Fti (250-400).Graph, dashboard, vector and visitag visualization features were used to visualize force.No additional visitag filters were used.The customer¿s reported issues of no temperature and/or no impedance readings are not life threatening and the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.Therefore, it is not mdr reportable.

Manufacturer Narrative

On 12/23/2019, the biosense webster inc.(bwi) product analysis lab (pal) received the complaint device for evaluation.Initial visual analysis observed there was no visual damage or anomalies.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, on 12/23/2019 additional information was received indicating the correct product involved in the event was a thermocool® smart touch® sf bi-directional navigation catheter.As such, the following fields have been updated: catalog # updated from d134804 to d134805, lot # updated from 30258732m to 30192481l, expiration date updated from 7/16/2020 to 3/21/2020, udi updated from (b)(4), device available for evaluation? from no to yes.Device manufacture date updated from 7/17/2019 to 3/22/2019.If any additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

Manufacturer Narrative

It was reported that a female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and cardiac tamponade occurred requiring pericardiocentesis.It was reported that during mapping for idiopathic ventricular tachycardia ablation in the right ventricular outflow tract (rvot) region in a patient with compact constitution, a small pericardial effusion was discovered with ultrasound.The effusion was assessed as ¿too small¿ to require drainage.The pericardial effusion was confirmed by ultrasound and comparing the image to the one taken at the beginning of the case (when no effusion was present).A few minutes later the physician attempted ablation, but the generator would not allow the burning since there was a temperature sensor error displayed on the remote, and no temperature was displayed for the catheter.There was also no impedance reading.The cable was replaced without resolution.At this time the effusion increased, and it was decided to perform pericardiocentesis.An unspecified amount of fluid was removed.After drainage and intubating patient, the patient was reported to be in stable condition.The catheter was then replaced, and procedure continued.The physician commented that since we could not come ablation, he did not want to continue using the ablator because he was not sure if there was a force error along with the no temperature (¿ablation¿) error.Device evaluation details: the device evaluation has been completed.The returned device was visually inspected, and it was found in normal conditions.A deflection test was performed, and the catheter passed.The catheter was also evaluated on carto system and the device was recognized, no error messages were displayed and was properly visualized.The force feature was also evaluated and work correctly.Then, electrical test was performed on the catheter and it was found within specifications; no electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.An irrigation test was performed and the catheter failed.Further examination showed that reddish material was a partially occluding inside catheter tip dome; this may be related to the device usage since irrigation feature is tested along the manufacturing process.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The catheter failed during irrigation test; however, the root cause of the pericardial effusion presented cannot be determined.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.The root cause of the partial occlusion in dome it seems to be related to the procedure and not related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (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: 9408346
• MDR Text Key: 169793921
• Report Number: 2029046-2019-03950
• 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: 11/05/2019

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: 03/21/2020
• Device Model Number: D134804
• Device Catalogue Number: D134805
• Device Lot Number: 30192481L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 12/23/2019; 01/03/2020
• Supplement Dates FDA Received: 12/27/2019; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; SOUNDSTAR CATHETER.; UNKNOWN TRANSEPTAL NEEDLE.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention