MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134804

Device Problem Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.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.Concomitant products: pentaray catheter, catalog and lot numbers unknown; thermocool smart touch sf d/f catheter, catalog and lot numbers unknown; smartablate pump, catalog and serial numbers unknown; smartablate tubing, catalog and lot numbers unknown; st.Jude medical agilis 8.5fr sheath, catalog and lot numbers unknown.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for left ischemic ventricular tachycardia with a thermocool smart touch bidirectional sf catheter where the deflection mechanism became stuck during the procedure.A retrograde approach was used to advance the pentaray nav catheter into the left ventricle, where the voltage map was created.At this point, the pentaray was removed from the patient¿s body, and the smart touch catheter was inserted with the same approach.The catheter was deflected, and the physician attempted to cross the aortic valve.After several failed attempts, the physician pulled the catheter back down to the insertion point while it was still in its deflected state.Further attempts to move the catheter were unsuccessful, even with the intervention of the vascular surgery team.The physician decided to connect a pressureized bag to the catheter and insert a second smart touch catheter via the femoral artery to perform the ablation.This was done without issue, and that catheter was removed from the patient¿s body after ablation.Interventional radiology was called at the end of the procedure, and they were able to successfully remove the deflected catheter from the patient¿s body with a snare device.The catheter was stuck for approximately 4 hours, but was removed without patient consequence or further intervention.While the catheter was stuck in the deflected state, it was noted that the knob/piston could not be manipulated.It is unknown if there was any damage to the catheter observed upon withdrawal.The sheath in use was a st.Jude medical agilis 8.5fr.If the catheter is stuck in the fully deflected state, there is a risk of injury to the patient.As a result, this event is mdr reportable.

Manufacturer Narrative

On 3/23/2018, additional information was received regarding the event.It was reported that the patient did not require extended hospitalization as a result of the adverse event.Patient fully recovered.Physician¿s opinion regarding the cause of the adverse event is that it was related to the procedure and the patient¿s condition and not related to the bwi product.Product investigation has been completed.Summary as follows: the returned device was visually inspected and it was found in good conditions.Then, deflection test was performed and the catheter failed.Failure analysis testing was performed and the catheter was dissected on the handle area and the puller wire was found detached from the brass ferrule causing a deflection issue, however, the catheter was not stuck or in a deflected position.Then, the catheter¿s outer diameter was measured and it was found within specification.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint regarding the deflection stuck cannot be confirmed.In addition, with the information received the physician has stated that the incident during the procedure was not due to the bwi product.The root cause of the adverse event cannot be determined.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.(b)(4).

Manufacturer Narrative

On 4/19/2018, additional information was received indicating the smarttouch sf catheter # 1 was entrapped due to the patient¿s anatomy and not due to any catheter malfunction.Physician¿s opinion regarding the cause of the adverse event is that it was related to the procedure and the patient¿s condition and not related to any bwi product malfunction.

Manufacturer Narrative

Corrections: describe event or problem is being corrected from: ¿it was reported that a patient underwent an ablation procedure for left ischemic ventricular tachycardia with a thermocool smart touch bidirectional sf catheter where the deflection mechanism became stuck during the procedure.A retrograde approach was used to advance the pentaray nav catheter into the left ventricle, where the voltage map was created.At this point, the pentaray was removed from the patient¿s body, and the smart touch catheter was inserted with the same approach.The catheter was deflected, and the physician attempted to cross the aortic valve.After several failed attempts, the physician pulled the catheter back down to the insertion point while it was still in its deflected state.Further attempts to move the catheter were unsuccessful, even with the intervention of the vascular surgery team.The physician decided to connect a pressureized bag to the catheter and insert a second smart touch catheter via the femoral artery to perform the ablation.This was done without issue, and that catheter was removed from the patient¿s body after ablation.Interventional radiology was called at the end of the procedure, and they were able to successfully remove the deflected catheter from the patient¿s body with a snare device.The catheter was stuck for approximately 4 hours, but was removed without patient consequence or further intervention.While the catheter was stuck in the deflected state, it was noted that the knob/piston could not be manipulated.It is unknown if there was any damage to the catheter observed upon withdrawal.The sheath in use was a st.Jude medical agilis 8.5fr.If the catheter is stuck in the fully deflected state, there is a risk of injury to the patient.As a result, this event is mdr reportable.¿ describe event or problem being corrected to: ¿it was reported that a patient underwent an ablation procedure for ventricular tachycardia with a thermocool smarttouch bidirectional sf catheter and suffered a medical device entrapment ¿ excessive manipulation required necessitating a surgical intervention.Pentaray catheter was advanced into the left ventricle via a retrograde aortic approach.Pentaray catheter was used to create a voltage map and to tag late potentials and other signals of interest.Pentaray catheter was removed from the body.Physician attempted to advance smarttouch sf catheter # 1 (f/j) into the left ventricle via a retrograde aortic approach.Smarttouch sf catheter # 1 was deflected and several attempts to cross the aortic valve were unsuccessful.Physician retracted smarttouch sf catheter # 1 toward the groin access site.Smarttouch sf catheter # 1 was stuck in a deflected position.Smarttouch sf catheter # 1 became entrapped in the femoral artery.Physician attempted to maneuver smarttouch sf catheter # 1 forward and backward without success.Vascular surgeon also attempted to maneuver smarttouch sf catheter # 1 without success.While smarttouch sf catheter #1 remained in the right femoral artery, a pressure bag and smartablate tubing were connected to smarttouch sf catheter # 2 (d/f) for the purpose of ablating the ventricular tachycardia.Smarttouch sf catheter # 2 was advanced via the left femoral artery and late potentials and other signals of interest were ablated.Upon completion of ablation, smarttouch sf catheter # 2 was removed from the patient¿s body.After being entrapped in the artery for approximately 4 hours, interventional radiology removed smarttouch sf catheter # 1 using a snare device.There were no further complications.The curve of smarttouch sf catheter # 1 was stuck in a fully deflected position.Knob/piston could be turned and/or pushed up and down.There was difficulty removing the catheter.There is no information regarding ring or other physical damage observed at the distal end of the catheter.Since this adverse event required medical/surgical intervention or prolonged hospitalization to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Additionally, the issues of catheter deflection being stuck and the catheter entrapment requiring excessive manipulation to remove from patient body are considered mdr reportable malfunctions.¿ date of this report being corrected from 1/6/2018 to 1/5/2018.(b)(4).The bwi failure analysis lab received the device for evaluation on 2/13/2018.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.Manufacturer's ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for ventricular tachycardia with a thermocool smarttouch bidirectional sf catheter and suffered a medical device entrapment ¿ excessive manipulation required necessitating a surgical intervention.Pentaray catheter was advanced into the left ventricle via a retrograde aortic approach.Pentaray catheter was used to create a voltage map and to tag late potentials and other signals of interest.Pentaray catheter was removed from the body.Physician attempted to advance smarttouch sf catheter # 1 (f/j) into the left ventricle via a retrograde aortic approach.Smarttouch sf catheter # 1 was deflected and several attempts to cross the aortic valve were unsuccessful.Physician retracted smarttouch sf catheter # 1 toward the groin access site.Smarttouch sf catheter # 1 was stuck in a deflected position.Smarttouch sf catheter # 1 became entrapped in the femoral artery.Physician attempted to maneuver smarttouch sf catheter # 1 forward and backward without success.Vascular surgeon also attempted to maneuver smarttouch sf catheter # 1 without success.While smarttouch sf catheter #1 remained in the right femoral artery, a pressure bag and smartablate tubing were connected to smarttouch sf catheter # 2 (d/f) for the purpose of ablating the ventricular tachycardia.Smarttouch sf catheter # 2 was advanced via the left femoral artery and late potentials and other signals of interest were ablated.Upon completion of ablation, smarttouch sf catheter # 2 was removed from the patient¿s body.After being entrapped in the artery for approximately 4 hours, interventional radiology removed smarttouch sf catheter # 1 using a snare device.There were no further complications.The curve of smarttouch sf catheter # 1 was stuck in a fully deflected position.Knob/piston could be turned and/or pushed up and down.There was difficulty removing the catheter.There is no information regarding ring or other physical damage observed at the distal end of the catheter.Since this adverse event required medical/surgical intervention or prolonged hospitalization to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Additionally, the issues of catheter deflection being stuck and the catheter entrapment requiring excessive manipulation to remove from patient body are considered mdr reportable malfunctions.

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7224913
• MDR Text Key: 98878567
• Report Number: 2029046-2018-01095
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2018

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: No Information
• Device Expiration Date: 09/27/2018
• Device Catalogue Number: D134804
• Device Lot Number: 17736988L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Manufacturer Received: 01/06/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 01/06/2018; 03/23/2018; 03/23/2018
• Supplement Dates FDA Received: 03/14/2018; 04/20/2018; 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention