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

Model Number D-1220-00

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Hematoma (1884); Hemoptysis (1887); Complaint, Ill-Defined (2331)

Event Date 05/30/2015

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.(b)(4).The device is not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 240 patients with af underwent catheter ablation from july 2013 and june 2015.Among them, 1 patient in group d developed hemoptysis, and the patient developed a large groin hematoma two days following the procedure and a high fever of 38.6°c.Dabigatran was discontinued imminently.Two days later, massive hemoptysis occurred and pulmonary computed tomography (ct) presented bilateral pulmonary frosted glass.At three days later, no hemoptysis occurred and a lung ct presented markedly reduced frosted glass.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: ¿use of dabigatran vs.Warfarin with low-molecular-weight heparin bridging in catheter ablation for atrial fibrillation patients with a low chads2 score¿.The purpose of this study was to compare the efficacy and safety of dabigatran and interrupted warfarin with low-molecular-weight heparin bridging in non-valvular atrial fibrillation (af) catheter ablation.Suspect device is a lasso 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: 6674685
• MDR Text Key: 78656789
• Report Number: 2029046-2017-00214
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/14/2017

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: 06/13/2017
• Initial Date FDA Received: 06/28/2017
• 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: 55 YR