MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_PENTARAY

Catalog Number UNK_PENTARAY

Device Problem Entrapment of Device (1212)

Patient Problem Rupture (2208)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

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 provided by the customer.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2019-03303, 2029046-2019-03304 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication.Since there is no information about the involved device all events are conservatively reported under biosense webster devices.1 patient underwent catheter ablation of atrial fibrillation and suffered mitral valve injury due to multipolar catheter entrapment.No additional details were provided.Multiple requests for clarification have been sent to the corresponding author, but no additional details were provided at this time.If additional details will be provided this report will be updated accordingly.There are 0 death events and 1 device malfunction reported in this publication.Model and catalog number are not available, but the suspected device is pentaray.Publication details: title: the impact of the presence of left atrial low voltage areas on outcomes from pulmonary vein isolation.Objective: in this study we evaluate the impact of left atrial (la) low voltage areas (lva) on response to afa.Methods: consecutive patients undergoing first-time radiofrequency afa were included (n = 160, 53% paf).Pvi was performed followed by la voltage mapping during sinus rhythm between january 2014 and september 2016.

• Brand Name: UNK_PENTARAY
• Type of Device: UNK
• 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: 8729627
• MDR Text Key: 149073844
• Report Number: 2029046-2019-03301
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/03/2019

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: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• 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: 60 YR