MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133601

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

Patient Problem No Code Available (3191)

Event Date 06/05/2019

Event Type  malfunction  

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 30137045m number, and no internal action was found during the review.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein the deflection became stuck and a medical device entrapment occurred requiring surgical intervention.During the procedure, the thermocool® smart touch¿ electrophysiology catheter¿s deflection mechanism was damaged, and the thermocool® smart touch¿ electrophysiology catheter got stuck into a fully deflected position inside the sheath (abbott 8.5 fr sl3 sheath).The sheath got kinked and stuck in patient¿s vessel.The thermocool® smart touch¿ electrophysiology catheter¿s knob/piston was unable to be turned and/or pushed up and down.There was no physical damage observed at the distal end of the catheter.Interventional radiologists support was required to remove the thermocool® smart touch¿ electrophysiology catheter and sheath from the patient¿s body.No problems occurred during the removing process.The thermocool® smart touch¿ electrophysiology catheter was replaced with a new thermocool® smart touch¿ catheter and the procedure was successfully completed.Patient¿s outcome is fully recovered.Extended hospitalization was not required.The physician attributed the causality of the event to the procedure and to the complex patient¿s vessel anatomy.The issues of the deflection getting stuck and device entrapment requiring surgical intervention for removal have been assessed as mdr reportable.

Manufacturer Narrative

On 6/28/2019, it was noticed that the concomitant products of abbott, 8.5f and sl3 sheath were inadvertently omitted from the 3500a initial mdr.Field concomitant products has now been populated.(both non-bwi products).Manufacturer's ref # (b)(4).

Manufacturer Narrative

On 7/1/2019, bionsense webster inc.(bwi) received additional information indicating the physician attributed the causality of the event to the procedure and to the complex patient¿s vessel anatomy and probably defective sheath.The device was used on the transseptal side.No issues occurred during the extraction and post procedure.On(b)(6)2019, bionsense webser inc.Received additional clarification about the event.It was reported that the during removal of the thermocool® smart touch¿ electrophysiology catheter the sheath remained stuck within the vessel and it was at this point that they realized the sheath had kinked within the vessel and this was what was holding the ablation catheter in the position it was.This was also why they couldn¿t advance the sheath further.The deflection mechanism on the thermocool® smart touch¿ electrophysiology catheter was broken, but the handle was not stuck in any position and once removed, the thermocool® smart touch¿ electrophysiology catheter could only sit in the undeflected position (not jammed).The catheter piston could be turned up/down but this did not result in any deflection of the catheter tip.The intervention to remove both, the catheter and the sheath was not surgical, it was using the normal access used for this type of procedure.Once the sheath was removed (after the thermocool® smart touch¿ electrophysiology catheter removal), which took another 30 minutes, the procedure continued as normal with no further incidents reported.Based on the additional information received this event is no longer mdr-reportable since it was clarified that the deflection was not stuck and no surgical intervention was required to remove the device from the patient.However, since this event has already been reported to fda, biosense webster inc.Will continue to report supplemental mdrs to fda as additional information is received regarding this event.On(b)(6)2019, the bwi product analysis lab received the 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.Manufacturer's ref.# pc-000477278.

Manufacturer Narrative

It was reported that a 47-year-old male patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein the deflection became stuck and a medical device entrapment occurred requiring surgical intervention.During the procedure, the thermocool® smart touch¿ electrophysiology catheter¿s deflection mechanism was damaged, and the thermocool® smart touch¿ electrophysiology catheter got stuck into a fully deflected position inside the sheath (abbott 8.5 fr sl3 sheath).The sheath got kinked and stuck in patient¿s vessel.The thermocool® smart touch¿ electrophysiology catheter¿s knob/piston was unable to be turned and/or pushed up and down.There was no physical damage observed at the distal end of the catheter.Interventional radiologists support was required to remove the thermocool® smart touch¿ electrophysiology catheter and sheath from the patient¿s body.No problems occurred during the removing process.On (b)(6) 2019, bionsense webster inc.(bwi) received additional information indicating the physician attributed the causality of the event to the procedure and to the complex patient¿s vessel anatomy and probably defective sheath.The device was used on the transseptal side.No issues occurred during the extraction and post procedure.On (b)(6) 2019, bionsense webser inc.Received additional clarification about the event.It was reported that the during removal of the thermocool® smart touch¿ electrophysiology catheter the sheath remained stuck within the vessel and it was at this point that they realized the sheath had kinked within the vessel and this was what was holding the ablation catheter in the position it was.This was also why they couldn¿t advance the sheath further.The deflection mechanism on the thermocool® smart touch¿ electrophysiology catheter was broken, but the handle was not stuck in any position and once removed, the thermocool® smart touch¿ electrophysiology catheter could only sit in the undeflected position (not jammed).The catheter piston could be turned up/down but this did not result in any deflection of the catheter tip.The intervention to remove both, the catheter and the sheath was not surgical, it was using the normal access used for this type of procedure.Once the sheath was removed (after the thermocool® smart touch¿ electrophysiology catheter removal), which took another 30 minutes, the procedure continued as normal with no further incidents reported.Based on the additional information received this event is no longer mdr-reportable since it was clarified that the deflection was not stuck and no surgical intervention was required to remove the device from the patient.However, since this event has already been reported to fda, biosense webster inc.Will continue to report supplemental mdrs to fda as additional information is received regarding this event.On (b)(6) 2019, the bwi product analysis lab received the device for evaluation.Initial visual analysis observed there was no visual damage or anomalies.On (b)(6) 2019, a scanning electron microscope (sem) analysis was conducted in the pebax area of the complaint device.¿the sem analysis results show evidence of mechanical damage, and a hole on the surface of the pebax.The object that caused the damage is unknown.No other anomalies were observed.¿ the findings were reviewed and assessed the ¿hole¿ on the pexax to be an mdr reportable malfunction since the integrity of the device was compromised.As such, this complaint continues to be not reportable for the reported event, however, becomes mdr reportable as of (b)(6) 2019 for the identified hole in the pebax.Device evaluation details: the device evaluation has been completed.The device was inspected and it was found in normal conditions, during the second visual inspection, reddish material was observed inside the pebax and the tip was observed pre-curved with a kink.A deflection test was performed and it was found within specifications, the catheter was deflecting correctly.A tilt test was performed and the catheter failed.The catheter was subjected to an electrical test and current leakage in all the electrodes was observed.After that, the catheter was connected to the carto 3 system and error 7 was observed on the screen.Irrigation test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.The catheter was dissected and reddish material and corrosion were observed on the pc board and connector area.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, and a hole on the pebax surface.Object that cause the damage is unknown.No other anomalies were observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the damage on pebax and the precurve observed on the catheter tip cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling/manipulation of the device during the procedure.In addition, the physician attributed the causality of the event to the procedure and to the complex patient¿s vessel anatomy and probably defective sheath.Note: field type of reportable event has been updated from serious injury to malfunction based on the additional information.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8743985
• MDR Text Key: 149558470
• Report Number: 2029046-2019-03351
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2019
• Device Catalogue Number: D133601
• Device Lot Number: 30137045M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT, 8.5F; SL3 SHEATH; ABBOTT, 8.5F; SL3 SHEATH
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR