MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1266-01-S

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Low Oxygen Saturation (2477); Loss Of Pulse (2562)

Event Date 06/06/2017

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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number can not be provided.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for non-ischemic ventricular tachycardia with a navistar rmt thermocool catheter and suffered a cardiac arrest requiring intubation, cardiopulmonary resuscitation (cpr), vasopressors, and extracorporeal membrane oxygenation (ecmo).During the procedure, the patient became hypoxemic.Despite intubation, oxygen saturation did not increase.Blood gases were drawn.Patient became hypotensive and pulseless electrical activity (pea) was diagnosed.Cardiopulmonary resuscitation (cpr) and vasopressors were administered.Ecmo was initiated.Patient was stabilized, ventilated, and transported to the intensive care unit (icu).Patient required extended hospitalization as a result of the adverse event.Patient outcome is improved.Medical history includes a biventricular implantable cardioverter-defibrillator (icd), non-ischemic cardiomyopathy, amiodarone, and aspirin.Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s pulmonary edema and low ejection fraction.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

The bwi failure analysis lab received the device for evaluation on 7/18/2017 and noted that the tip of the catheter was not straight as it had a wavy appearance.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.The wavy appearance on the catheter 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.Originally, the lot number was reported as unknown.However, during the biosense webster failure analysis lab investigation, the lot number was able to be retrieved.The lot number is 17636739m.Therefore, the manufactured date, expiration date, udi number have been provided.Therefore, expiration date, manufactured date, and udi # have been populated.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) year old male patient underwent an ablation procedure for non-ischemic ventricular tachycardia with a navistar rmt thermocool catheter.During the procedure, the patient became hypoxemic.Despite intubation, oxygen saturation did not increase.Blood gases were drawn.Patient became hypotensive and pulseless electrical activity (pea) was diagnosed.Cardiopulmonary resuscitation (cpr) and vasopressors were administered.Ecmo was initiated.Patient was stabilized, ventilated, and transported to the intensive care unit (icu).Patient required extended hospitalization as a result of the adverse event.Patient outcome is improved.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for carto 3 and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Then the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Additionally, a deflection and an irrigation test were performed and the catheter passed the tests.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 cardiac arrest and heart failure remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6673729
• MDR Text Key: 78607443
• Report Number: 2029046-2017-00212
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: UNKNOWN_D-1266-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 06/06/2017; 06/06/2017
• Supplement Dates FDA Received: 08/02/2017; 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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: 49 YR
• Patient Weight: 106