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

Catalog Number D133601

Device Problems Bent (1059); Device Damaged by Another Device (2915)

Patient Problems Vascular Dissection (3160); Not Applicable (3189)

Event Date 04/01/2018

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(s) 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.Manufacturer's ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and suffered a medical device entrapment (requiring surgical intervention) and a vascular dissection (requiring surgical intervention).During the procedure, while in the descending aorta, the shaft of the thermocool® smart touch¿ electrophysiology catheter formed a loop.Upon attempting to retrieve the smarttouch catheter, it became entrapped in the femoral artery.Physician manipulated the catheter with twisting and turning motions in an attempt to release the loop in the shaft of the smarttouch catheter.Remainder of procedure was aborted.A surgical intervention was required.Post-removal of the thermocool® smart touch¿ electrophysiology catheter, a vascular dissection was detected 2 cm above the vascular access site.A surgical intervention was performed.Patient required extended hospitalization as a result of the adverse event for surgical recovery.No transseptal puncture was performed.A cordis 15 cm 8 french sheath was used.There were no reports of wires being exposed and no reports of lifted or sharp rings.Photos provided by the customer did reveal a kink on the shaft of the catheter.The report of the catheter forming a loop and the shaft being bent, is not a reportable issue.However, since the medical device entrapment required surgical intervention to remove the catheter from the patient's body it is an mdr reportable event.Additionally, since this adverse event of vascular dissection required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

On 6/27/2018, the bwi failure analysis lab (fal) received the device for evaluation.Initial visual analysis found kinks on catheter shaft approximately 28.5 cm and 420 cm from distal tip and electrode # 6 was found damaged.These findings were assessed and determined the kinks are not reportable, however, the electrode damage is an mdr reportable malfunction.Product evaluation summary: it was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and suffered a medical device entrapment (requiring surgical intervention) and a vascular dissection (requiring surgical intervention).The returned device was visually inspected and kinks were found along the shaft and the electrode #6 was found damage.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Force sensor was tested and it was working properly, the force values were observed within specifications.An electrical test was performed on the catheter and 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.Then, the irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.Then, the catheter 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.On line, functional tests are in place to prevent this type of failure from leaving the facility.The catheter passed all specifications.The root cause of the adverse event remains unknown.The ifu states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the damage observed on the shaft and on the electrode could be related to the handling of the device.Manufacturer's ref # (b)(4).

Manufacturer Narrative

On 6/4/2018, additional information was received indicating the complaint device was discarded.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: 7497290
• MDR Text Key: 107689780
• Report Number: 2029046-2018-01525
• 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
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2018
• Device Catalogue Number: D133601
• Device Lot Number: 17763815M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention