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 Laceration(s) of Esophagus (2398)

Event Date 12/31/2015

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 no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.It was reported 2 patients with drug-refractory persistent atrial fibrillation (af) underwent radiofrequency ablation and developed esophageal thermal lesions that recovered under treatment with proton pump inhibitors.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: ¿durability of wide-area left atrial appendage isolation: results from extensive catheter ablation for treatment of persistent atrial fibrillation.¿ the purpose of this study was to assess the durability of wide-area left atrial appendage isolation (laai) achieved by pvi, an anterior line, and a mitral isthmus line.71 patients have been enrolled between march 2003 to september 2015.Suspect device is lasso catheter, however catalog and lot number are unknown.

Manufacturer Narrative

This report is to provide attachment of the article (complaint source).(b)(4).

• 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: 6237638
• MDR Text Key: 64366187
• Report Number: 2029046-2017-00015
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR