• 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. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

  • 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. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053 Back to Search Results
Model Number D-1336-00
Device Problem Insufficient Information (3190)
Patient Problem Hematoma (1884)
Event Date 03/16/2017
Event Type  Injury  
Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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 can not be provided.Concomitant medical products: carto 3 system; model #: m-4800-01; serial #: unknown.(b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a thermocool smarttouch uni-directional catheter and suffered a hematoma, pulmonary congestion, and a urinary infection.There is no information about the hospitalization and if any intervention was performed.No information is known regarding the patient status.The physician did not provide a causality opinion for the cause of this adverse event.Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.
 
Manufacturer Narrative
This is a correction as in the 3500a initial report the following statement was added in error: ¿since the lot number is unknown, the full udi number can not be provided.¿ manufacturer's ref.No: (b)(4).
 
Manufacturer Narrative
Additional information was received on the event on june 8, 2017.The patient also suffered post-procedure dyspnea (requiring no medical or surgical intervention).The dyspnea issue is ongoing.The principal investigator assessed the dyspnea as possibly procedure-related.(b)(4).
 
Manufacturer Narrative
Additional information was received regarding interventions and patient outcomes on september 22, 2017.During the procedure, the patient developed a hematoma.No interventions were performed.Issue resolved without sequelae.Principal investigator assessed this event as mild in severity, not serious, not investigational device-related, and definitely index procedure-related.On post-procedure day 2, the patient developed a urinary tract infection.An unspecified medication was administered.Issue resolved without sequelae.Principal investigator assessed this complaint as moderate in severity, not serious, not investigational device-related, and probably index procedure-related.On post-procedure day 2, the patient developed pulmonary edema.An unspecified medication was administered.Issue resolved without sequelae.Principal investigator assessed this event as moderate in severity, not serious, not investigational device-related, and probably index procedure-related.On post-procedure day 1, the patient developed dyspnea.No interventions were administered.Issue resolved without sequelae.Principal investigator assessed this event as mild in severity, not serious, not investigational device-related, and possibly index procedure-related.(b)(4).
 
Manufacturer Narrative
Originally, the product reported was a thermocool smarttouch uni-directional catheter / model #: d-1336-00 / lot #: unknown_d-1336-00.Additional information was received on september 4, 2017 providing a corrected product.The correct product is thermocool smarttouch bidirectional navigation catheter / model #: d-1327-05-s/lot #: unk_d-1327-05-s.Since the lot number is unknown, the full udi number can not be provided.(b)(4).
 
Manufacturer Narrative
Additional information was provided on march 11, 2019 stating that the patient was a 66 year old female.Legacy manufacturer¿s reference number: (b)(4).Manufacturer¿s reference number: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
Type of Device
SIMILAR DEVICE D133601, PMA # P030031/S053
Manufacturer (Section D)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX  32599
MDR Report Key6490158
MDR Text Key72780652
Report Number9673241-2017-00274
Device Sequence Number1
Product Code OAD
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,Followup,Followup,Followup,Followup
Report Date 04/04/2017
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 NumberD-1336-00
Device Catalogue NumberD133600
Device Lot NumberUNKNOWN_D-1336-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/16/2017
Initial Date FDA Received04/13/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
03/16/2017
03/16/2017
03/11/2019
Supplement Dates FDA Received04/14/2017
06/14/2017
09/05/2017
10/17/2017
04/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
-
-