MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1183-08-S

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 01/16/2017

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.Full udi # information unavailable since the lot number is unknown.Concomitant products: webster cs with auto id catheter (model# d-1353-04-s lot# unknown), c3 cs refstar deflectable catheter (model# d-1285-02-s lot# unknown), pentaray nav eco catheter (model# d-1282-11-s lot# unknown).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for atrial tachycardia under general anesthesia with a navistar¿ electrophysiology catheter and suffered a cardiac arrest requiring cardiopulmonary resuscitation (cpr) and cardioversion.Post-procedure, after removing the catheters and applying pressure to the femoral access site, the patient was emerging from general anesthesia.Patient suddenly became bradycardic and went into ventricular fibrillation cardiac arrest.Cpr was initiated and synchronized direct current (dc) cardioversion was performed several times resulting in monomorphic ventricular tachycardia.After a final cardioversion, the patient was in sinus rhythm.Immediately after the event, the patient was stabilized and transferred to the intensive care unit.Patient required extended hospitalization as a result of the adverse event for follow-up post cardiac arrest.Patient fully recovered.Adverse event was noted to be life-threatening.Medical history includes dilated cardiomyopathy and unspecified arrhythmias.Physician¿s opinion regarding the cause of the adverse event is that it may have been related to a medication that was administered while reversing anesthesia.Physician indicated that the adverse event was not related to the use of biosense webster inc.Products.It was also noted that the patient¿s baseline cardiovascular condition was suboptimal.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 6306226
• MDR Text Key: 66662959
• Report Number: 2029046-2017-00025
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P990025
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1183-08-S
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: UNKNOWN_D-1183-08-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• 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
• Patient Age: 13 YR