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

Model Number D-1197-16-S

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

Patient Problems Death (1802); Hematoma (1884); Respiratory Distress (2045); Paraplegia (2448)

Event Date 10/31/2015

Event Type  Death  

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 the no lot number was provided by the customer.Concomitant products: carto mapping system, lasso catheter.Other companies¿ devices were used in this study: a 64-pole basket catheter (constellation, boston scientific), firm (abbott electrophysiology).Manufacturer's ref.No: (b)(4) the device is not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 170 consecutive patients with paf (37%), persistent atrial fibrillation (peaf) (31%), long-standing persistent atrial fibrillation (lpeaf) (32%), or paroxysmal atrial fibrillation (paf) (37%) underwent catheter ablation from january 2012 to october 2015.This is iu-firm registry and focal impulse and rotor modulation (firm) with an endocardial basket catheter was used in all cases.Among them, one (b)(6)male patient suffered epidural hematoma.Patient required extended hospital stay.Spinal hematoma was enlarged and caused paraplegia as well as respiratory problems; patient declined further therapy and died.Navistar thermocool catheter was used in this event.The author stated that the event was not related to bwi device; the event was led by anticoagulation only and patient condition related.Title: ¿clinical benefit of ablating localized sources for human atrial fibrillation¿ the purpose of this study was to analyze the role of rotors and focal sources in a large academic registry of consecutive patients undergoing source mapping for af.

• Brand Name: NAVISTAR® THERMOCOOL®
• 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: 6570221
• MDR Text Key: 75275199
• Report Number: 2029046-2017-00162
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2017

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-1197-16-S
• Device Catalogue Number: NI75TCDH
• Device Lot Number: UNKNOWN_D-1197-16-S IRW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 72 YR