MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Biosense webster manufacturer's report number 2029046-2020-00767 is related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled ¿multi-electrode mapping of complex macroreentry atrial tachycardia.¿ 3 patients with atrial tachycardia related to scarring who underwent conventional activation mapping (cam) and the following ablation experienced right femoral artery pseudoaneurysms.This study aimed to evaluate mem for the analysis and treatment of complex macroreentry atrial tachycardia (mat).Methods: patients with mat related to scarring, history of heart surgery, or atrial linear ablation were studied.Patients were mapped with conventional activation mapping (cam) or mem.After characterizing the mechanism of atrial tachycardia, the ablation was performed.The study consisted of 114 eligible patients, 74 in the cam and 40 in mem.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: CARDIAC MAPPING CATHETER, PERCUTANEOUS, SINGLE-USE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 10202546
• MDR Text Key: 198871708
• Report Number: 2029046-2020-00766
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/26/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR