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 Cardiac Tamponade (2226); No Code Available (3191)

Event Date 01/07/2019

Event Type  Injury  

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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.

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¿.A (b)(6) years old female patient with structural heart disease (shd) who have focal ventricular tachycardia (vt) who underwent undergoing vt ablation developed pericardial tamponade with post-procedural hemodynamic collapse that required urgent pericardiocentesis and pericardial drain but no need for cardiac surgery (attributed to intraprocedural perforation of the cs catheter).

• 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: 9910702
• MDR Text Key: 191696799
• Report Number: 2029046-2020-00506
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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
• Date Manufacturer Received: 03/11/2020
• 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): Required Intervention
• Patient Age: 75 YR