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 Problem Nerve Damage (1979)

Event Date 05/01/2013

Event Type  Injury  

Event Description

Event description: this complaint is from literature source.From the article-1 patient experienced transient phrenic nerve palsy in the pvi + svci group.Title: remote-controlled magnetic pulmonary vein isolation combined with superior vena cava isolation for paroxysmal atrial fibrillation: a prospective randomized study.Objectives: this prospective, randomized study sought to investigate the efficacy of additional superior vena cava isolation (svci) combined with pulmonary vein isolation (pvi) in symptomatic paroxysmal atrial fibrillation (paf) patients referred for ablation.From (b)(6) 2011 to (b)(6) 2013, radiofrequency ablation (rfa) was performed remotely using a carto® 3 system in patients randomized to undergo pvi pulmonary vein isolation for symptomatic drug-refractory paroxysmal atrial fibrillation (paf), with (pvi + svci group) or without (pvi alone group) svci.Pvi and svci were confirmed by spiral catheter recording during ablation.Procedural data, complications and freedom from atrial tachycardia (at) and atrial fibrillation (af) were assessed.Adverse events were reported in this article: 1 patient experienced severe symptomatic pulmonary stenosis requiring stenting in the pvi alone group; 1 patient experienced transient ischemic attack with complete recovery in the pvi alone group; 1 patient experienced phrenic nerve injury with partial recovery in the pvi + svci group.There are no death events and device malfunctions reported in the publication.Bwi products reported in the article: non-fluoroscopic navigation system (carto®3 system), lasso catheter and thermocool navistar rmt catheter.Other companies devices : niobe®ii rmns (stereotaxis), deflectable quadripolar catheter 5 mm interelec-trode spacing; xtrem; ela medical, (b)(4); navigant 2.1;stereotaxis inc., (b)(4)).

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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.The 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 cannot be provided.Bwi concomitant products used: product name: lasso 2550; us catalog #: unknown; lot#: unknown.Product name: carto®3 system; us catalog #: unknown; serial #: unknown.Non-bwi products used: niobe®ii rmns (stereotaxis), deflectable quadripolar catheter 5 mm interelec-trode spacing; xtrem; ela medical, (b)(4); navigant 2.1;stereotaxis inc., (b)(4).(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: shahe garabedian ; 9098397362
• MDR Report Key: 4725042
• MDR Text Key: 5743565
• Report Number: 2029046-2015-00123
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2015

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
• Other Device ID Number: (01)10846835008500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2007
• 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): Other
• Patient Age: 56 YR