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

Catalog Number UNK_PENTARAY

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

Patient Problems Death (1802); No Code Available (3191)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

(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 no lot number was provided by the customer.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿focal ventricular tachycardias in structural heart disease prevalence, characteristics, and clinical outcomes after catheter ablation.¿ 1 patient with structural heart disease (shd) who have focal ventricular tachycardia (vt) who underwent undergoing vt ablation died within 30 days after readmission with multiorgan dysfunction without recurrent vas.

• Brand Name: UNK_PENTARAY
• 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: 9835808
• MDR Text Key: 183550278
• Report Number: 2029046-2020-00418
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/24/2020

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_PENTARAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/16/2020
• 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): Death
• Patient Age: 66 YR