MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_LASSO; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number UNK_LASSO

Device Problem Entrapment of Device (1212)

Patient Problems Rupture (2208); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Karabulut mn, akay mh, salas de armas ia, gregoric id.Emergent valve replacement after circular mapping catheter entrapment in mitral valve apparatus.Interact cardiovasc thorac surg.2021 jun 28;33(1):136-138.Doi: 10.1093/icvts/ivab042.Pmid: 34118156.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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: karabulut mn, akay mh, salas de armas ia, gregoric id.Emergent valve replacement after circular mapping catheter entrapment in mitral valve apparatus.Interact cardiovasc thorac surg.2021 jun 28;33(1):136-138.Doi: 10.1093/icvts/ivab042.Pmid: 34118156.Objective: the purpose of this article is to present a case of entrapment of a cardiac mapping catheter in the mitral valve causing damage that required emergent open-heart surgery and mitral valve replacement.Methods/study data: a (b)(6) male with symptomatic paroxysmal af resistant to medical treatment and cardioversion was referred for cardiac ablation.The left atrial appendage was of normal size with no evidence of left atrial thrombus.The mitral and tricuspid valves showed unremarkable anatomy and function.All pulmonary veins opened to the left atrium in normal anatomic configuration.The interatrial septum was crossed with 2 transseptal sl1tm (st jude medical) sheaths.Transseptal access allowed for a thermocool smarttouch catheter (4 mm, bwi) to pass through 1 sheath and a lasso circular mapping catheter (bwi) was passed through the other.While the lasso catheter was being repositioned, it became lodged within the mv apparatus.Different maneuvers, including rotation, traction and straightening, were applied multiple times and by different operators.All attempts to dislodge the device failed.Emergency open-heart surgery ensued, and an intraoperative tee confirmed severe mitral regurgitation due to the coiled catheter.An aortic and double venous cannulation was performed, and the heart was arrested by antegrade, cold-crystalloid cardioplegia infusion.The surgeon identified that the lasso had punctured the posterior mitral annulus at the 4 o¿clock position and was wrapped around the chordae.The posterior mitral leaflet was also punctured, and the catheter passed around and through the posterior papillary muscle.The posterior mitral leaflet, posterior annulus, and papillary muscle were destroyed.The lasso was cut into pieces and removed.The surgeons noted that repair of the mv was not possible and chose to replace it with a mechanical prosthetic valve.The left atrial appendage was ligated with a 4mm atriclip.The postoperative course was uncomplicated.The patient remained in a sinus rhythm and was discharged home on day 7 on warfarin.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: lasso circular mapping catheter other biosense webster devices that were also used in this study: thermocool smarttouch 4mm ablation catheter non-biosense webster devices that were also used in this study: 2 transseptal sl1 (st jude medical) sheaths.Adverse event(s) and provided interventions: mitral valve regurgitation, mitral valve rupture, and papillary rupture secondary to lasso catheter entrapment with excessive manipulation.Treated with open heart surgery with mechanical mitral valve replacement, left atrial appendage ligation, and lasso removal.

• Brand Name: UNK_LASSO
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12601284
• MDR Text Key: 282770611
• Report Number: 2029046-2021-01712
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial
• Report Date: 10/08/2021

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_LASSO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 TRANSSEPTAL SL1 (ST JUDE MEDICAL) SHEATHS; THERMOCOOL SMARTTOUCH 4MM ABLATION CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR