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

Catalog Number UNK_PENTARAY

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: saluveer o, bastani h, verouhis d, källner g, jensen-urstad m.Transseptal access through an atrial septal defect closure device resulting in open heart surgery.Jacc case rep.2022 jun 1;4(11):685-687.Doi: 10.1016/j.Jaccas.2022.04.006.Pmid: 35677791; pmcid: pmc9168954.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 not provided by the customer.Product complaint # (b)(4).

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: saluveer o, bastani h, verouhis d, källner g, jensen-urstad m.Transseptal access through an atrial septal defect closure device resulting in open heart surgery.Jacc case rep.2022 jun 1;4(11):685-687.Doi: 10.1016/j.Jaccas.2022.04.006.Pmid: 35677791; pmcid: pmc9168954.Objective/methods/study data: a case study of a 45 year old man with history of tachycardia-mediated cardiomyopathy and impaired left ventricular ejection fraction of 25%, owing to persistent atrial fibrillation (af).Cardiac magnetic resonance showed an asd secundum with 2.1:1 shunt, and percutaneous closure of the asd was performed.The asd was sized to 27 mm and closed with a 30-mm occlutech asd occluder device (occlutech) without any residual shunt.At follow-up, the patient still experienced symptomatic persistent af and was referred for pulmonary vein isolation (pvi).During ablation procedure, a pentaray mapping catheter (biosense webster) was advanced through the sheath to the la.Attempts to further advance the mapping catheter in the la failed because the catheter was trapped in the device.Attempts to release the catheter from the device failed.The procedure was converted to cardiac surgery with the patient under cardiopulmonary bypass.The device with the trapped catheter was explanted.The 30-mm asd defect was closed with a bovine pericardial patch, and a cryomaze procedure was performed.Postoperative care was complicated by pericarditis requiring pericardiocentesis.At follow-up, the patient had a stable sinus rhythm.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: pentaray catheter other biosense webster devices that were also used in this study: n/a.Concomitant non-biosense webster devices that were also used in this study: asd closure device, agilis sheath (abbott).Adverse event(s) and provided interventions: qty 1 entrapped pentaray treated with surgical intervention with complications of pericarditis.

Manufacturer Narrative

During an internal review on 06-sep-2022, the imdrf clinical symptoms code of pericarditis (e0620) was added to this complaint.Therefore, h 6.Health effect - clinical code has been updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15317627
• MDR Text Key: 298872961
• Report Number: 2029046-2022-02032
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

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_PENTARAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 10/04/2022
• 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
• Treatment: AGILIS SHEATH (ABBOTT); ASD CLOSURE DEVICE
• Patient Outcome(s): Life Threatening; Required Intervention