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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_OCTARAY NAV; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

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BIOSENSE WEBSTER INC UNK_OCTARAY NAV; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Catalog Number UNK_OCTARAY NAV
Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/18/2023
Event Type  Injury  
Manufacturer Narrative
An article/literature was received entitled ¿a multipolar electrode mapping catheter and a mechanical valve: to use or not to use?" 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.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).
 
Event Description
An article/literature was received entitled ¿a multipolar electrode mapping catheter and a mechanical valve: to use or not to use?" a 65 year old woman with a history of a mechanical mitral valve (mmv), hypertrophic cardiomyopathy, and multiple ablation procedures for atrial fibrillation and atrial flutter presented to the electrophysiology lab for another attempt to treat her atrial arrhythmias.During left atrial (la) mapping, a portion of the octaray catheter became entrapped in the mmv.With gentle traction and clockwise torque, the catheter was freed from this without requiring unusual force; however, on one of the splines of the catheter, recordings were lost; the catheter was removed from the long introducer sheath in the la and inspected, showing that the distal-most 3 of 6 microelectrodes on one spline were missing (fig 1a).The patient remained stable throughout this process.Fluoroscopy of the mmv showed no evidence of the retained electrodes; likewise, cinefluoroscopy of the head showed no evidence of electrodes in this region.After ensuring that the patient was hemodynamically stable and there were no ecg changes, the procedure was continued without event.Three reentrant atypical left atrial flutters were mapped and eliminated with radiofrequency energy and were non-inducible at the end of the ablation protocol.At the conclusion of the procedure, fluoroscopy was performed of the entire body, showing that the severed electrodes had more than likely lodged in an artery branch in the right gluteal region (fig 1b).Colleagues from interventional radiology determined that an angiogram was not necessary and that the retained electrodes were in an artery branch that posed her no harm and consequently were not worth attempting to retrieve.She continued to do well post-procedure and was discharged home the following day without symptoms.
 
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Brand Name
UNK_OCTARAY NAV
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 32599
MX   32599
Manufacturer Contact
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key17666063
MDR Text Key322446299
Report Number2029046-2023-01967
Device Sequence Number1
Product Code MTD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2023
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? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_OCTARAY NAV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2023
Initial Date FDA Received08/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient SexFemale
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