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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR® THERMOCOOL®; SIMILAR DEVICE NI75TCJH, PMA # P030031 Back to Search Results
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)).
 
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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 Key6005775
MDR Text Key56768828
Report Number2029046-2016-00185
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD-1197-00
Device Catalogue NumberD119700
Device Lot NumberUNKNOWN_NAVISTAR THERMO TC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/12/2016
Initial Date FDA Received10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age54 YR
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