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

Catalog Number UNK_LASSO

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: patel n, mariner d, vijayaraman p.Successful percutaneous extraction of a circular mapping catheter entrapped in a chiari network.J interv card electrophysiol.2021 oct;62(1):213-214.Doi: 10.1007/s10840-020-00921-9.Epub: 2021 jan 5.Pmid: 33398499.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.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 Description

This complaint is from a literature source.The following literature cite has been reviewed: patel n, mariner d, vijayaraman p.Successful percutaneous extraction of a circular mapping catheter entrapped in a chiari network.J interv card electrophysiol.2021 oct;62(1):213-214.Doi: 10.1007/s10840-020-00921-9.Epub: 2021 jan 5.Pmid: 33398499.Objective/methods/study data: case study of a 57 year old man who underwent successful pulmonary vein isolation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: lasso mapping catheter.Other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: while creating an electroanatomic right atrial map, the catheter was noted to be entrapped at the right atrium-inferior vena cava junction (chiari network) - released by a 20-mm circular snare and glide wire were advanced via the right jugular vein to lock the glide wire and then pulling from both femoral and jugular access points freed the catheter with a network of fibrous tissue of the chiari network.No complications were observed.No patient harms noted.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12841276
• MDR Text Key: 285826972
• Report Number: 2029046-2021-01998
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/18/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/18/2021
• 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): Required Intervention