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

Catalog Number D134701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Ventricular Fibrillation (2130)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered ventricular fibrillation requiring external defibrillation and extracorporeal membrane oxygenation (ecmo) and hypoxic-ischaemic encephalopathy.The patient had a planned ventricular tachycardia (vt) ablation for recurrent icd shocks.Mapping was done utilizing a large agilis sheath, a pentaray navigational eco catheter and a thermocool® smart touch® sf uni-directional navigation catheter.At the end of the mapping phase, the patient developed slow vt (130bpm).Then, when mapping the left ventricle (lv) with the thermocool® smart touch® sf uni-directional navigation catheter, a faster vt was mechanically induced that developed to ventricular fibrillation (vt).External defibrillation was performed.Patient returned to sinus for several before going to fast vt/vf again.Electrical storm couldn¿t be terminated.Hospital internal emergency team was called and installed ecmo on the operating table to stabilize circulation and decreased pump function of heart.Patient¿s condition worsened and had glascow coma scale of 4 points.The patient was breathing by himself; however, reacted inadequate to stimulation and developed severe brain damage.Extended hospitalization was required as a result of the adverse event.No biosense webster, inc.Product malfunctions were reported.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9082750
• MDR Text Key: 161307607
• Report Number: 2029046-2019-03653
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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