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

Model Number D134701

Device Problem Bent (1059)

Patient Problem Cardiac Tamponade (2226)

Event Date 07/28/2017

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.The device history record (dhr) for the lot number 17642825l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with two thermocool smarttouch sf catheters and suffered a cardiac tamponade requiring pericardiocentesis.When the first thermocool smarttouch sf catheter (lot #: 17642858l) was placed in the patient, the vector displayed as inverted.Force vector inversion persisted upon contact with the anterior and posterior walls.Catheter was zeroed, catheter was reconnected, and cable was exchanged without resolution.The first thermocool smarttouch sf catheter was exchanged for the second thermocool smarttouch sf catheter (lot #: 17642825l) and the issue resolved.The force vector inversion issue noted on the first thermocool smarttouch sf catheter was assessed as not reportable as the potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.During the procedure, the sheath and/or the second thermocool smarttouch sf catheter seemed to be kinking and the catheter was difficult to handle.Catheter was forcibly maneuvered in the area of the left carina, which resulted in a perforation, as evidenced by a change in cardiac silhouette movement.Pericardiocentesis yielded an unspecified amount of fluid.Patient was transferred to the intensive care unit in stable condition.There is no information regarding extended hospitalization.Patient outcome is improved.It was noted that there were no difficulties with removing the catheter.No physical damage, such as exposed wires, was reported.It was noted that the adverse event might have occurred during mapping phase.There were no factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure or patient condition.Transseptal puncture was performed with an unspecified needle.There is no sheath information.Generator was set on power control mode.There is no information regarding generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, irrigated catheter flow setting, or anticoagulation during the procedure.There is no information regarding shaft proximity interference value, catheter proximity, or catheter zeroing.There were no errors reported on any bwi equipment during the procedure.Since this adverse event 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

Initially, the usage of device was unknown.However, additional information was received updating usage of device to ¿initial use of device¿.(b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine 92618 ; 949789-383
• MDR Report Key: 6812102
• MDR Text Key: 83297684
• Report Number: 9673241-2017-01003
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(11)170313(17)180227(10)17642825L
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 17642825L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention