MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR® THERMOCOOL®; SIMILAR DEVICE NI75TCJH, PMA # P030031

Model Number D-1197-00

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

Patient Problem Hematoma (1884)

Event Date 09/30/2014

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 the no lot number was provided by the customer.Concomitant medical product: carto mapping system.Other company¿s devices were used during this study: rf marinr ((b)(4)), coolpath or coolflex ((b)(4)), other irrigated rf technology (brand unspecified), velocity mapping system ((b)(4)), 8.5-fr agilis nxt ((b)(4)), swartz sheath sl0 or sl1.Methods: no testing methods performed (b)(4).Results: no results available since no evaluation performed (b)(4).Conclusion: device discarded by user, unable to follow-up (b)(4).(b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 3 patients developed arterio-venous fistula.These patients required surgical repair.Based on the facts of the case and the author¿s assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title:"immediate post-procedure bridging with unfractioned heparin versus low molecular weight heparin in patients undergoing radiofrequency ablation for atrial fibrillation with an interrupted oral anticoagulation strategy.¿ the purpose of this study was to compare the incidence of major complications associated with post-procedural use of low molecular weight heparin (lmwh) versus unfractioned heparin (ufh) as a bridge to reinitiation of oral anticoagulation after an af ablation procedure.The study was conducted from january 2009 to september 2014.A total of 744 procedures were performed in the 3 participating institutions.Suspected device is navistar thermocool ablation catheter, however catalog and lot number are unknown.Concomitant products were used during this study: lasso, ez steer thermocool.Other company¿s device was used during this study: duodecapolar circular mapping catheter (optima®, (b)(4)).

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: SIMILAR DEVICE NI75TCJH, PMA # P030031
• 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: 6005775
• MDR Text Key: 56768828
• Report Number: 2029046-2016-00185
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1197-00
• Device Catalogue Number: D119700
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• 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): Other; Required Intervention
• Patient Age: 54 YR