MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) GENERIC-EZ STEER TCOOL NON NAV; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1295-00

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

Patient Problem Hematoma (1884)

Event Date 07/30/2012

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.Since the lot number is unknown, the full udi number cannot be provided.Concomitant products were used during this study: carto 3 system.(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.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 that one paroxysmal atrial fibrillation patient in the control group developed hematoma which was managed medically.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: "real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results." the purpose of this study was to investigate the additional benefit of contact force technology during pulmonary vein isolation for paroxysmal atrial fibrillation to improve mid-term clinical outcome.Other adverse events were reported in this article: - 1 patient in control group arteriovenous fistula managed medically; - 1 patient in control group pericardial effusion treated conservatively; - 1 patient in cf group hematoma managed medically; - 2 patients in cf group pericardial effusion treated conservatively; suspected device is ez steer thermocool ablation catheter, however catalog and lot number are unknown.Concomitant products were used during this study: carto 3 system.

• Brand Name: GENERIC-EZ STEER TCOOL NON NAV
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 5030099
• MDR Text Key: 24047694
• Report Number: 9673241-2015-00561
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1295-00
• Device Catalogue Number: D129500
• Device Lot Number: UNKNOWN_EZ_STEER_TC_NNAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• 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; Required Intervention
• Patient Age: 61 YR