MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) GENERIC - LASSO

Model Number D-1220-00

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 12/31/2013

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 no lot number was provided by the customer.Concomitant product used in this study: carto mapping system.(b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.Four hundred seventy one patients with paroxysmal atrial fibrillation underwent pvi for the first time.Of these, 23 suffered major complications, which were represented by a bar graph, therefore estimated.Of the 23 complications, approximately 1 patient suffered intracranial hemorrhage.There is no information regarding intervention.The remainder of the complications cited in this article will be reported separately.Based on the facts of the case and the author's assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title: "who is the operator, that is the question: a multicentre study of catheter ablation of atrial fibrillation." the purpose of this study was to test whether the procedure volume of each operator was associated with the outcome of af ablation in high-volume centres.Four hundred seventy one patients with paroxysmal af underwent pulmonary vein (pv) isolation for the first time.The study was conducted from january 2012 to december 2013 suspect device is a lasso mapping catheter, however catalog and lot number is unknown.

• Brand Name: GENERIC - LASSO
• Type of Device: GENERIC - LASSO
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6001624
• MDR Text Key: 56541882
• Report Number: 2029046-2016-00180
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

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 Model Number: D-1220-00
• Device Catalogue Number: D122000
• Device Lot Number: UNKNOWN_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR