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 Pneumothorax (2012)

Event Date 08/16/2016

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 no lot number was provided by the customer.Other company¿s devices were used during this study: 8-fr long sheath (sl0, af division, sjm, (b)(4), usa), computer-based digital recording system (labsystem pro, bard electrophysiology, (b)(4), usa), 28-mm second-generation cb (arctic front advance, medtronic, (b)(4), usa), 7fr 20-pole three site mapping catheter (beeat, (b)(4)-life-line, (b)(4)) , rf needle (baylis medical, inc., (b)(4)) ,15-fr steerable sheath (flexcath advance, medtronic),spiral mapping catheter (achieve, medtronic) (b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that one patient with paroxysmal atrial fibrillation (paf) underwent cryothermal pvi and suffered a pneumothorax during the puncture of the right subclavian vein, which was not associated with the cb procedure.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: "pulmonary vein isolation using a second-generation cryoballoon in patients with paroxysmal atrial fibrillation: one-year outcome using a single big-balloon " 108 patients were enrolled in the study.The purpose of this study was to assess the 1-year clinical outcome after second-generation cb ablation with single 3-minute freeze techniques, and clinical variables associated with af recurrence.

• 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: 5992428
• MDR Text Key: 56102275
• Report Number: 2029046-2016-00154
• 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: 09/08/2016

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: 09/07/2016
• Initial Date FDA Received: 09/30/2016
• 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: 64 YR