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. SMARTABLATE¿ IRRIGATION TUBING SET; 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. SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number SAT001
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
The biosense webster inc.Failure analysis lab (fal) received the complaint product for evaluation on (b)(6) 2018.Initial visual analysis identified, ¿tubing and drip chamber are clear with no signs of foreign material.¿ the analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
 
Event Description
It was reported that a patient, underwent an ablation procedure with a smartablate¿ irrigation tubing set and after priming was conducted, the tube became cloudy and small air bubbles remained.The issue was encountered during flushing process with no error codes/alarm being generated by the pump.The tubing set was changed, and the issue resolved.The procedure was completed with no patient consequence.The issue of air bubbles in the tube is not mdr reportable since air bubbles are an expected part of the set-up process and flushing should be performed to remove the bubbles.Also, a safety feature of the pump is in place in order to stop flow if air is detected.However, the issue of the ¿cloudiness¿ believed to be foreign material in the tubing has been assessed as a reportable malfunction.
 
Manufacturer Narrative
On (b)(6) 2018, it was noticed that this event was incorrectly assessed as a reportable event.This event is not mdr reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On (b)(6) 2018, 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).
 
Manufacturer Narrative
It was reported that a patient, underwent an ablation procedure with a smartablate¿ irrigation tubing set and after priming was conducted, the tube became cloudy and small air bubbles remained.The issue was encountered during flushing process with no error codes/alarm being generated by the pump.The tubing set was changed, and the issue resolved.The procedure was completed with no patient consequence.On (b)(6)2018 , it was noticed that this event was incorrectly assessed as a reportable event.This event is not mdr reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Device evaluation details: the device evaluation has been completed.The complaint product was inspected and it was found in normal condition.Tubing and drip chamber are clear with no signs of foreign material.Irrigation test was performed and tubing pass specification.No microbubbles were found in the tubing after flushing.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.Complaint was not confirmed.Manfuacturer¿s ref # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SMARTABLATE¿ IRRIGATION TUBING SET
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key8076182
MDR Text Key127353790
Report Number2029046-2018-02290
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835009743
UDI-Public10846835009743
Combination Product (y/n)N
PMA/PMN Number
P990017/S17
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Catalogue NumberSAT001
Device Lot NumberAC3812860
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Initial Date Manufacturer Received 10/23/2018
Initial Date FDA Received11/15/2018
Supplement Dates Manufacturer Received11/19/2018
12/28/2018
Supplement Dates FDA Received12/11/2018
01/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-