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

Catalog Number D134805

Device Problems Low impedance (2285); Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/14/2018

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.The device history record (dhr) for the lot number 17749240l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: smartablate generator, us catalog #: unknown, serial #: unknown.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent a cavotricuspid isthmus (cti) ablation procedure for typical atrial flutter with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis and pericardial drain.During ablation, impedance decreased to the low cut-off and a steam pop occurred.System stopped ablation when the impedance low cut-off was met.Cardiac tamponade was confirmed via echocardiography.Pericardiocentesis yielded 350 ml.Pericardial drain was left in place.Patient was reported to be in stable condition.Patient required extended hospitalization (overnight) in the intensive care unit (icu) for pericardial drain maintenance.Patient fully recovered.Patient factors cited that may have contributed to the adverse event include that the cti had a large pouch.Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s anatomy.There were no issues or errors reported with any biosense webster, inc.Products or equipment during the procedure.No transseptal puncture was performed.No long sheaths were used.Generator parameters at the time of injury included power control mode at 35 watts with temperature warning at 37 degrees celsius and temperature cut-off at 40 degrees celsius.Generator settings at the time of injury included power at 35 watts, temperature at 32 degrees celsius, and impedance of approximately 100 ohms (with impedance average of 110 ohms).Length of the ablation cycle when the steam pop occurred was at the same tip position was 47 seconds.Power was not titrated.Overall ablation time at the site of injury was 47 seconds.Last ablation cycle time at the site of injury was 47 seconds.Irrigated catheter flow was set at 2 ml/min during mapping and 15 ml/min during ablation.Patient received anticoagulant (heparin) during the procedure with activated clotting time (act) maintained in an unspecified range.There is no information regarding shaft proximity interference value.Thermocool® smart touch® sf bi-directional navigation catheter was not in close proximity to another catheter.Thermocool® smart touch® sf bi-directional navigation catheter was zeroed after the initial warm-up phase, post catheter connection to the carto 3 patient interface unit.Carto 3 system did not indicate to re-zero the catheter.There were no issues or errors reported with any biosense webster, inc.Products or equipment during the procedure.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.The ¿low impedance¿ issue was assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event was remote.The ¿steam pop¿ issue was assessed as not reportable as it is an expected physiological phenomenon and not considered to be a device malfunction.

Manufacturer Narrative

The biosense webster inc.Failure analysis lab received the device for evaluation on 4/17/2018.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.No: (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that a (b)(4) year-old male patient underwent a cavotricuspid isthmus (cti) ablation procedure for typical atrial flutter with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis and pericardial drain.During ablation, impedance decreased to the low cut-off and a steam pop occurred.System stopped ablation when the impedance low cut-off was met.Cardiac tamponade was confirmed via echocardiography.Pericardiocentesis yielded 350 ml.Pericardial drain was left in place.Patient was reported to be in stable condition.Patient required extended hospitalization (overnight) in the intensive care unit (icu) for pericardial drain maintenance.Patient fully recovered.Patient factors cited that may have contributed to the adverse event include that the cti had a large pouch.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested and it was working properly, the force values were observed within specifications.Then, electrical test was performed on the catheter and it was 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.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 catheter passed all specifications.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.Manufacturer's reference number: (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: 7336909
• MDR Text Key: 102305007
• Report Number: 2029046-2018-01313
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17749240L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 129