• 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) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

  • 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) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Model Number D-1282-10-S
Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2016
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. As such, the investigation will be closed. If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate. The device history record (dhr) for the lot number 17511629l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures. Concomitant products: carto 3 system, model #: m-4800-01, serial #: (b)(4); smartablate generator, model #: m-4900-07, serial #: (b)(4); smartablate pump, model #: m-4900-08, serial #: (b)(4); smarttouch bidirectional catheter, model #: d-1327-05-s, lot #: 17525651m; soundstar eco catheter, model #: m-5723-15, lot #: unknown. Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a pentaray navigational eco catheter and suffered a medical device entrapment. During the procedure, the pentaray catheter was inadvertently passed through the prosthetic mitral valve. There was resistance/difficulty during removal of the catheter since the spine was stuck in the prosthetic mitral valve. Upon attempting to remove the catheter, the last 2 electrodes and the dome tip of one of the spines became lodged in the valve and detached from the catheter. It was noted that the spine detachment did result in wires and/or braid being exposed. Damage did not result in any lifted or sharp edges. Remainder of the procedure was aborted. The patient was reported to be in stable condition. There is no information regarding extended hospitalization. The detached spine tip re-located from the mitral valve to an unspecified location in a lower extremity. The physician to follow up with interventional radiology to discuss treatment options. There is no information regarding the treatment decision or the patient outcome. The physician's opinion regarding the cause of the adverse event is that it was procedure-related and patient-related (prosthetic mitral valve). 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
Type of DeviceCATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX 32599
Manufacturer (Section G)
BIOSENSE WEBSTER, INC. (JUAREZ)
circuito interior norte #1820
parque industrial salvacar
juarez, chihuahua 32599
MX 32599
Manufacturer Contact
joaquin kurz
33 technology drive
irvine, CA 92618
9497893837
MDR Report Key6054805
MDR Text Key58308925
Report Number9673241-2016-00725
Device Sequence Number1
Product Code MTD
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 09/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2019
Device MODEL NumberD-1282-10-S
Device Catalogue NumberD128210
Device LOT Number17511629L
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/04/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/25/2016 Patient Sequence Number: 1
-
-