Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NON NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NON NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number UNK_THERMOCOOL SF NON NAV
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Nerve Damage (1979); Cardiac Tamponade (2226); Pseudoaneurysm (2605)
Event Date 07/26/2021
Event Type  Injury  
Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: ukita k, egami y, kawamura a, nakamura h, matsuhiro y, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, yano m, nishino m, tanouchi j.Clinical impact of very early recurrence of atrial fibrillation after radiofrequency catheter ablation.J cardiol.2021 aug 20:s0914-5087(21)00199-4.Doi: 10.1016/j.Jjcc.2021.08.004.Epub ahead of print.Pmid: 34426045.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 lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).
 
Event Description
This complaint is from a literature source.The following literature cite has been reviewed: ukita k, egami y, kawamura a, nakamura h, matsuhiro y, yasumoto k, tsuda m, okamoto n, matsunaga-lee y, yano m, nishino m, tanouchi j.Clinical impact of very early recurrence of atrial fibrillation after radiofrequency catheter ablation.J cardiol.2021 aug 20:s0914-5087(21)00199-4.Doi: 10.1016/j.Jjcc.2021.08.004.Epub ahead of print.Pmid: 34426045.Objective: ¿the aim of this study was to elucidate the characteristics and significance of very early recurrence of af (veraf) after rfca.¿ methods/study data: ¿a total of 610 patients underwent an initial rfca of af between september 2014 and april 2019 in our hospital.Among them, 201 patients experienced eraf (defined as recurrence of af within 3 months after rfca).These patients were categorized into three groups: group a who experienced recurrence of atrial tachyarrhythmia only within 48 h after rfca, group b who experienced recurrence of atrial tachyarrhythmia both within 48 h and between 48 h and 3 months after rfca, and group c who experienced the first recurrence of atrial tachyarrhythmia between 48 h and 3 months after rfca.¿ lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouchtm (biosense webster) other biosense webster devices that were also used in this study: carto3 (biosense webster).Pentaray (biosense webster).Non-biosense webster devices that were also used in this study: duodecapolar catheter (beeat).8.5fr sl0 (st jude medical).Adverse event(s) and provided interventions: (3) cardiac tamponade.(6) phrenic nerve injury.(4) femoral pseudoaneurysm.Treatments relating to adverse events nor outcomes were provided within the article.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK_THERMOCOOL SF NON NAV
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
MDR Report Key12607179
MDR Text Key282900112
Report Number2029046-2021-01728
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_THERMOCOOL SF NON NAV
Was Device Available for Evaluation? No
Date Manufacturer Received09/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8.5FR SL0 (ST JUDE MEDICAL); CARTO3 (BIOSENSE WEBSTER); DUODECAPOLAR CATHETER (BEEAT); PENTARAY (BIOSENSE WEBSTER)
Patient Outcome(s) Life Threatening;
-
-