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

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.

• 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 Key: 17666063
• MDR Text Key: 322446299
• Report Number: 2029046-2023-01967
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• 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 Number: UNK_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 Received: 08/31/2023
• 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 Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female