• 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-1282-11-S
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 06/22/2017
Event Type  Injury  
Manufacturer Narrative

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) was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).

 
Event Description

It was reported that a patient underwent an ablation procedure for atrial tachycardia with a pentaray nav eco high density mapping catheter and suffered a medical device entrapment. While mapping in the left atrium with the pentaray nav eco catheter, one of the spines became entrapped in the mechanical mitral valve and could not be removed. Physician attempted to open the valve with the ablation catheter and the spine was successfully removed. Fluoroscopy and echocardiogram confirmed normal valve functioning. Subsequently, mapping and ablation continued via the ablation catheter. Procedure was completed. There is no information regarding extended hospitalization. Patient fully recovered. It was noted that the physician was aware of the contraindication of using the pentaray catheter with a mechanical valve. Physician indicated that he has decided to no longer use the pentaray catheter in patients with mechanical valves. Physician's opinion regarding the cause of the adverse event is that it was related to procedure or patient condition.

 
Manufacturer Narrative

Notified by the biosense webster failure analysis lab on 08/08/2017 of the returned catheter condition: spine arm damaged pulled causing rings to come off the base on spine arm. The bwi failure analysis lab received the device for evaluation on 08/08/2017. The analysis has begun but is not completed at this time. It was discovered that there was spine arm was damaged causing rings to come off the base of the spine arm. Additional information was received that this condition was not noticed prior to the catheters use. This finding is mdr reportable due to the possible risk to the patient which may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. (b)(4).

 
Manufacturer Narrative

(b)(4). It was reported that a patient underwent an ablation procedure for atrial tachycardia with a pentaray nav eco high density mapping catheter and suffered a medical device entrapment. The returned catheter was inspected and it was found a spine arm damaged, rings to come off the base on spine arm, the rings were # 5, 6, 7 and 8. The catheter was evaluated for eeprom, carto 3 and sensor functionality. The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized. Eeprom data demonstrates the catheter was properly calibrated during manufacturing. Then a deflection test was performed and the catheter passed. Then the catheter was tested for electrical performance and it was found within specifications. Additionally, a flow test was performed and the catheter was flushing correctly. Then the catheter outer diameter was measured and it was found within specification. The device history record (dhr) was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. During manufacturing process, all the catheters are inspected for visual damages before packaging. On line inspections and functional tests are in place to prevent this type of damage from leaving the facility. The catheter passed all specifications, the damage reported has been verified. The root cause of the damage could be related to the use of the catheter during the procedure, however this cannot be conclusively determined.

 
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 Key6712272
MDR Text Key80018974
Report Number9673241-2017-00574
Device Sequence Number1
Product Code MTD
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/23/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2020
Device MODEL NumberD-1282-11-S
Device Catalogue NumberD128211
Device LOT Number17652916L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/08/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/22/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/07/2017
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: 07/13/2017 Patient Sequence Number: 1
-
-