MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-05-S

Device Problems Kinked (1339); Device Dislodged or Dislocated (2923)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Cardiac Arrest (1762); Myocardial Infarction (1969); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

Cardiopulmonary resuscitation (cpr) was administered.Echocardiogram revealed a pericardial effusion.Patient was reported to have stable cardiac function.Thermocool smarttouch bidirectional navigation catheter was surgically removed and the effusion was drained.Tissue was attached to the tip of the catheter.Tissue sample was sent to histology to confirm if it was venous material.Chest incision was closed.Postoperative scans were performed.Loop recorder was removed.Patient required extended hospitalization in the intensive care unit (icu) as a result of the adverse event.Patient outcome was improved at the time of complaint update.Patient¿s neurologic status will be assessed after extubation in the morning.Factors cited that may have contributed to the adverse event include possible atypical anatomy.The physician is uncertain if the adverse it was secondary to atypical anatomy or a product malfunction.No transseptal puncture was performed.Sheath used was unknown.Generator settings, overall ablation time at the site of injury, and last ablation cycle time at the site of injury were not reported, as no ablation was performed.It was noted that impedance rose to approximately 200 ohms when the catheter was entrapped.Force visualization features used included dashboard and vector.No visitag was used, as no ablation was performed.Irrigated catheter flow was set on 2 ml/min on standby, 30 ml/min and 60 ml/min while attempting to dislodge the catheter.Patient did not receive anticoagulant during the procedure.There is no information regarding the shaft proximity interference value.Thermocool smarttouch bidirectional navigation catheter was not in close proximity to another catheter.Thermocool smarttouch bidirectional navigation catheter was not yet zeroed.Alerts indicated that the catheter needed to be zeroed and that respiration gating should be performed.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.In addition, ten smart touch bidirectional catheter tips from the past few weeks from previous procedures were retrieved.While manually feeling the tips, they were believed to have ¿sharp¿ edges as they were not as smooth as expected.They noted that the area on the catheter tip which got caught under the reported manufacturer (b)(4) correlates with the area of roughness on some of these catheter tips.Therefore, we have also reported these ten catheters under biosense webster manufacturer's (b)(4).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 17647937m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent a right ventricular outflow tract (rvot) ablation procedure for premature ventricular contractions (pvcs) with a thermocool smarttouch bidirectional navigation catheter and suffered a medical device entrapment (requiring surgical intervention), vascular dissection (no intervention noted), acute myocardial infarction (no intervention noted), cardiac arrest (requiring cardiopulmonary resuscitation), and cardiac tamponade (requiring drainage).During mapping phase, the thermocool smarttouch bidirectional navigation catheter was inserted into the right atrium and positioned in the coronary sinus to collect data regarding left vs right heart origin of ectopic beats.While in the coronary sinus, the thermocool smarttouch bidirectional navigation catheter entered a venous branch and became entrapped.Manual removal attempts were unsuccessful.Fluoroscopy revealed the thermocool smarttouch bidirectional navigation catheter to be located in the coronary sinus with a kinked tip.Contrast administered via the thermocool smarttouch bidirectional navigation catheter revealed that it was occluding the vein, but there was no evidence of vascular dissection.Verapamil was administered to dilate the vein.Irrigated catheter flow setting was adjusted to 30 ml/min in an attempt to help dislodge the thermocool smarttouch bidirectional navigation catheter.Contrast was administered a 2nd time and revealed a minor vascular dissection.Irrigated catheter flow rate was temporarily increased to 60 ml/min.Interventional radiologist attempted to dislodge the catheter.A non-bwi 5 french sheath was inserted.Ecg changes included left bundle branch block (lbbb), suspected st elevation, and ventricular tachycardia.

Manufacturer Narrative

On 6/13/2017, the bwi failure analysis lab received the device for evaluation.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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) male patient underwent a right ventricular outflow tract (rvot) ablation procedure for premature ventricular contractions (pvcs) with a thermocool smarttouch bidirectional navigation catheter and suffered a medical device entrapment (requiring surgical intervention), vascular dissection (no intervention noted), acute myocardial infarction (no intervention noted), cardiac arrest (requiring cardiopulmonary resuscitation), and cardiac tamponade (requiring drainage).The returned device was visually inspected, and it was found in good condition.No sharp edges were observed.Foreign/reddish material present during a preliminary visual inspection was not observed.This could be related to the decontamination process.The catheter was evaluated for carto 3 system performance, and was recognized by the system with no error messages and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.The catheter was subjected to a screening test, which passed.The force feature was working properly, and the force sensor values were found within specifications.The catheter was tested for electrical performance and stockert compatibility, and was found within specifications.Deflection and irrigation tests were performed, which the catheter passed.The catheter outer diameter was measured, and was found within specifications.A meeting with the manufacturing team was performed to investigate the reported issue, and it was concluded that it was not related to the manufacturing process.There is no evidence that might suggest that the reported failure mode could be related to the manufacturing process.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 state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6617106
• MDR Text Key: 76832530
• Report Number: 9673241-2017-00439
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)170314(17)180227(10)17647937M
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• 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: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17647937M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 14 YR