MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	UNK_OPTRELL MAPPING CATHETER
Medical Device Problem Codes	Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: usman bhatti, ethan hacker, jonathan m.Burnett, sunny s.Po.(may 2024).Deer stuck in a fence; entrapment of high-density grid mapping catheter (optrell) in mitral subvavlvular apparatus.Heart rhythm society.Po-02-027.Https://doi.Org/10.1016/j.Hrthm.2024.03.907.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 no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 ref #: (b)(4).
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: usman bhatti, ethan hacker, jonathan m.Burnett, sunny s.Po.(may 2024).Deer stuck in a fence; entrapment of high-density grid mapping catheter (optrell) in mitral subvavlvular apparatus.Heart rhythm society.Po-02-027.Https://doi.Org/10.1016/j.Hrthm.2024.03.907.Objective/methods/study data: background: a 55 year old male with ischemic cardiomyopathy was referred to electrophysiology lab for vt ablation.A novel grid catheter, optrell (biosense webster, ca) was used to map lv via retro-aortic approach.Objective(s): first known case of entrapment of the optrell catheter in the mitral apparatus.Additionally we describe our multi-modality approach to rescue the situation and avoid emergent surgery.Method(s): while mapping the lv, the catheter became difficult to manipulate, we noticed narrowing of the splines around the middle like in a noose.Ice and fluoroscopy verified this concern.Gentle rotation, advancement and retraction failed to free the catheter.Attempt to use ablation catheter via transseptal to push the optrell apically failed.Tee showed catheter entangled in the chordae leading to severe mitral regurgitation.We then utilized the retrospective review feature (cartoreplay) of mapping system (carto 3; biosense webster, ca) and were able to visualize the exact catheter movements leading to entrapment.We saw that catheter entered lv directing to basal lateral wall.Attempting to map the basal anteroseptal wall, a clockwise rotation & then complete retro-flexion of optrell was performed, resulting in the splines getting pinched in middle.Result(s): fortunately, we were successful in performing all these maneuvers in the exact stepwise but opposite fashion to untangled the catheter from the subvalvular apparatus and retract it back to the aorta.Tee afterwards showed no valvular complication and resolution of mitral regurgitation.Conclusion(s): use of the grid mapping catheter may present a potential hazard in patients with lax subvalvular apparatus.Although the bi-directional deflection of optrell catheters increases maneuverability, caution should be taken if catheter manipulation becomes difficult, especially in a retro-aortic approach.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: optrell.Concomitant biosense webster devices that were used in this study: carto concomitant non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified optrell: qty 1 ¿ 55 year old male with ischemic cardiomyopathy experienced severe mitral regurgitation (mitral valve incompetence) (serious injury) as a result of (medical device entrapment ¿ excessive manipulation required).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 19618157
• Report Number: 2029046-2024-02098
• Device Sequence Number: 6963593
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_OPTRELL MAPPING CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male