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

Catalog Number D134805

Device Problems Entrapment of Device (1212); Material Puncture/Hole (1504); Mechanical Jam (2983)

Patient Problems Vascular Dissection (3160); No Code Available (3191)

Event Date 08/03/2018

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.The device history record (dhr) for the lot number 30058243l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for idiopathic ventricular tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter and suffered iliac artery dissection requiring no medical/surgical intervention and a medical device entrapment due to the deflection mechanism of the catheter being stuck requiring excessive manipulation and surgical intervention to remove it from patient's body.During the procedure, the mid-shaft of the thermocool® smart touch® sf bi-directional navigation catheter was kinked.The kink caused the f curve to be stuck in a fully deflected position.The knob/piston was unable to be turned and/or pushed up and down.The kink did not result in internal wires being exposed.There was no resistance or difficulty during the catheter insertion.The physician had to apply excessive manipulation to remove the catheter from the patient¿s body.Access to the other iliac artery was obtained in order to snare the catheter to try and pull the curve straight to pull it out of the patient¿s body.The catheter was replaced, and the issue resolved.After the case, the patient complained of having pain in the groin area.It was then discovered that the patient had an iliac artery dissection.No medical/surgical intervention was required.The patient was reported to be in stable condition.The patient had to spend the night at the hospital.Patient¿s outcome is fully recovered with no residual effects.Physician¿s opinion regarding the cause of the patient event is that it occurred due to the kink on the catheter which caused the catheter to be stuck in a fully deflected position inside the patient¿s body.It would be likely that the artery dissection occurred during the catheter manipulation when trying to remove it from patient¿s body.

Manufacturer Narrative

On 12/11/2018, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.During initial visual analysis the following was identified: kink in the shaft, 161/2 inches from the black rubber of the catheter handle.Dark red / brown material in the pebax.Looks like transition at peek housing is slightly separated.Bent helix spring.Catheter was stuck in a curve.The finding of the catheter being stuck in a curve coincides with the customer¿s complaint and continues to be reportable.The other findings have been assessed as not reportable since the catheter integrity appears to be maintained and no internal components are exposed to the patient.This does not present a potential consequence for the patient other than a possible procedural delay.On 12/20/2018, further product analysis which included a scanning electron microscope (sem).Sem showed evidence of mechanical damage, stress marks, scratches and a hole on the pebax surface.It is possible that the damage was generated with an unknown object.No other anomalies were observed.This finding of hole on the pebax has been assessed as an mdr reportable malfunction.Device codes 1212 (entrapment of device) was inadvertently omitted in the 3500a initial mdr.The code has now been added to section.Manufacturer¿s ref #: (b)(4).

Manufacturer Narrative

It was reported that a male patient underwent an ablation procedure for idiopathic ventricular tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter and suffered iliac artery dissection requiring no medical/surgical intervention and a medical device entrapment due to the deflection mechanism of the catheter being stuck requiring excessive manipulation and surgical intervention to remove it from patient's body.On 12/20/2018, further product analysis which included a scanning electron microscope (sem).Sem showed evidence of mechanical damage, stress marks, scratches and a hole on the pebax surface.It is possible that the damage was generated with an unknown object.No other anomalies were observed.This finding of hole on the pebax has been assessed as an mdr reportable malfunction.Device evaluation details: the device evaluation has been completed.The device was inspected and a kink was observed on the shaft, dark red material was observed inside the pebax, the peek housing was found slightly separated, the tip was found bent.The magnetic sensor functionality was tested on carto and the catheter failed, error 105 and 106 were observed.A failure analysis was performed and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.Then, an electrical test was performed and the catheter failed, no electrical readings were observed on electrode # 2.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.In addition, the thermocouple values were found out of spec.A failure analysis was performed and it was found that there is an electrical intermittence on the tip area creating the temperature issue.Then, the tilt test was performed and the tip was found out of specs, this could be related to the manipulation of the device during the procedure.A deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was dissected on the handle area and the puller wire was found detached from the brass ferrule causing the deflection issue.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, stress marks, scratches and a hole on the pebax surface.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint regarding the bent shaft was confirmed.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.The root cause of the damage on pebax cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The root cause of the bent shaft and the bent tip are related to the manipulation of the device during the procedure.The root cause of the electrical wire breakage cannot be determined.The temperature failure is detectable in production, however, the wires can break during the procedure due to the manipulation of the device.This failure does not represent any patient safety impact.The root cause of the internal failure of the sensor cannot be determined, however, an internal corrective action has been opened to investigate the issue of sensor failure.Patient code 3191 (no code available) reported in the initial mdr was used to represent ¿surgical intervention¿.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: 7834992
• MDR Text Key: 118869309
• Report Number: 2029046-2018-01992
• 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,Followup
• Report Date: 08/03/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30058243L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 12/11/2018; 01/14/2019
• Supplement Dates FDA Received: 01/04/2019; 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention