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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Low Blood Pressure/ Hypotension (1914); Ambulation Difficulties (2544)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: mullins long transseptal sheath.(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 bilateral thalamic infarcts requiring multiple computed tomography (ct) scans and magnetic resonance imaging (mri).At the conclusion of the procedure, the patient did not awaken as expected.Neurological testing was performed, as a procedure-related neurological event was suspected.Initially, computed tomography (ct) ruled out an embolic stroke.Patient was reported to be in stable condition.Later cts and an mri revealed bilateral thalamic infarcts.No new medications were administered.Patient required extended hospitalization as a result of the adverse event for neurological testing.Patient was discharged with memory intact and a normal cognitive state.Patient currently has an abnormal gait and impaired level of alertness.Patient will attend physical rehabilitation for up to 6 months.Physician¿s initial opinion regarding the cause of the adverse event was that it was procedure-related.After conferring with other electrophysiologists and a neurologist, the physician believes that the patient¿s pre-procedure hypertension followed by the anesthetic technique of maintaining a relatively hypotensive state during the procedure, was likely the cause.It was also noted that there was speculation that tiny microbubbles may have contributed to the multiple areas of infarct.The sheath in use during the event was a mullins long transseptal sheath.

Manufacturer Narrative

On 10/16/2017, the 6-month patient status follow up was completed.The patient was discharged from the hospital after the event with a few new medications (anti-lipid, unspecified).The neurology team was not convinced that the event was a result of hypoperfusion, and that bilateral embolic strokes were a possibility.The patient still has cognitive deficiencies, and though most abilities are intact, there is short term memory loss and attentional difficulties.These issues have improved, and should continue to improve per the neurologists.However, the patient is on disability and can no longer work.(b)(4).

• 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: 6490513
• MDR Text Key: 72743756
• Report Number: 2029046-2017-00120
• Device Sequence Number: 1
• Product Code: OAD
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

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 Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: UNKNOWN_D-1266-01-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 03/24/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 56 YR