• 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 PENTARAY NAV HIGH-DENSITY MAPPING ECO 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 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Model Number D128211
Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184); Contamination /Decontamination Problem (2895); Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and a biosense webster, inc.Product analysis lab observed ¿electrode damage¿ and ¿foreign particles in electrodes¿.Initially it was reported that there was no visualization of one spline of the catheter.Also, there was noise on the catheter.In visualization, no spline or dark black electrode number 13-14 and 15-16.The cable was changed but problem remained the same.The catheter needed to be changed and the problem solved.No patient consequence was reported.The visualization issue was assessed as not mdr reportable.The device is not visualized by the carto system.The user will have to replace the catheter in order to complete the case.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The noise issue was assessed as not mdr reportable.The risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 16-dec-2021 there was damages on several rings and foreign material found under some electrodes in the spline d.The returned condition was assessed as mdr reportable for both ¿electrode damage¿ and ¿foreign particles in electrodes¿.The awareness date for these reportable lab findings was 16-dec-2021.
 
Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 02-nov-2021.The device evaluation was completed on 16-dec-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, electrical and fourier transform infrared spectroscopy (ftir) evaluation of the returned device.Visual analysis of the returned sample revealed damages on several rings and foreign material found under some electrodes in the spline d of the pentaray nav eco device.An electrical test was performed, and the device failed; no electrical readings were observed on the damaged electrodes, 13,14, and 15.The failure during the testing could be related to the damage found in the electrodes causing that the electrical wire was found broken, provoking the improper electrical signal.The foreign material found was analyzed and revealed that it is primarily composed of acrylonitrile butadiene styrene - base material (abs).However, the source of origin remains unknown.As part of bwi's quality process, all devices are manufactured, inspected, and released to approved specifications.To avoid physical damages to spline, the following guidelines should be followed.Do not introduce the pentaray¿ naveco catheter into a guiding sheath with its distal splines folded backwards (i.E., toward the handle).Collapse the splines together using the insertion tube prior to insertion; and this catheter is recommended for use with an 8 f guiding sheath as the distal splines may be damaged if used with a sheath that is not compatible to minimize ecg noise, the following guidelines should be followed.Ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on (b)(6)2022, noted a correction to the 3500a as h10.Additional manufacturer narrative as it should have included, ¿a manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
Type of Device
CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez
MX  
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key13201749
MDR Text Key288364841
Report Number2029046-2022-00047
Device Sequence Number1
Product Code MTD
UDI-Device Identifier10846835012255
UDI-Public10846835012255
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2022
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 Date01/11/2024
Device Model NumberD128211
Device Catalogue NumberD128211
Device Lot Number30502640L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/09/2022
Initial Date FDA Received01/09/2022
Supplement Dates Manufacturer Received01/09/2022
Supplement Dates FDA Received01/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER
-
-