MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC ABLATION CATHETER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Necrosis (1971); Rupture (2208); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: sun zw, wu bf, ying x, zhang bq, yao l, zheng lr.Delayed papillary muscle rupture after radiofrequency catheter ablation: a case report.World j clin cases.2021 jul 16;9(20):5556-5561.Doi: 10.12998/wjcc.V9.I20.5556.Pmid: 34307609; pmcid: pmc8281425.Objective: the purpose of this article is to report a case where mvp and papillary muscle rupture occurred 2 weeks after rfca in a papillary muscle originated vt patient without mitral valve regurgitation or prolapse before.Pathological examination revealed necrosis of the papillary muscle.The patient underwent mitral valve replacement and fully recovered.Methods/study data: a (b)(6) man who received aortic valve replacement 4 years ago due to aortic regurgitation.In (b)(6) 2020 since he experienced syncope with a five-minute loss of consciousness.The holter monitor showed paired ventricular premature contraction and paroxysmal ventricular tachycardia.Echocardiography revealed no mitral stenosis or regurgitation present at that time.The lvef was 65% and the function of the aortic bioprosthetic valve was normal.The electrophysiology study and rfca were performed using a 3-dimensional mapping system (carto univ; bwi).The three- dimensional geometries of the left ventricle (lv) and the papillary muscles were reconstructed by intracardiac echocardiography (ice) (soundstar; bwi).Ablation was performed using a bwi navistar thermocool smart touch unipolar ablation catheter.The ablation was successful, and no intraoperative or postoperative complications were noted during the patient¿s hospitalization of one week.Two-weeks after rfca, the patient experienced dyspnea.Echocardiography showed severe mitral valve prolapse.The patient received mitral valve replacement.During the operation, the papillary muscle was found to be ruptured and was entering into the left atrium, with another end in the left ventricle.The patient received mitral valve replacement.During the operation, the papillary muscle was found to be ruptured and was entering into the left atrium, with another end in the left ventricle.Pathological examination revealed necrosis of the papillary muscle.The surgery was successful with no complications reported at 6 months follow-up.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: soundstar-bwi: intracardiac echocardiography used to reconstruct papillary muscles.Navistar thermocool smart touch-bwi: ablation catheter other biosense webster devices that were also used in this study: carto univ.Non-biosense webster devices that were also used in this study: na adverse event(s) and provided interventions: dyspnea associated with severe mitral valve prolapse due to the delayed postoperative rupture and necrosis of the papillary muscle.Treated with mitral valve replacement.Images available on fig2, a-e on pp.5".

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: CARDIAC ABLATION CATHETER
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12395649
• MDR Text Key: 269269014
• Report Number: 2029046-2021-01460
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR