MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NON NAV; SIMILAR DEVICE D131501, PMA # P030031/S034

Catalog Number UNK_THERMOCOOL SF NON NAV

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/31/2016

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.(b)(4).

Event Description

This complaint is from a literature source.It was reported that one patient underwent pulmonary vein isolation and experienced a steampop along with cardiac tamponade.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: ¿management of cardiac tamponade in catheter ablation of atrial fibrillation: single-centre 15 year experience on 5222 procedures¿ the purpose of this study was to investigate the incidence, predictors, and management of cardiac tamponade in a single educational centre large patient cohort undergoing af ablation over 15 years.The study was conducted between 2002 and 2016.The 4 mm tip ablation catheter (fantasista, japan life line), 3.5 mm externally irrigated-tip ablation catheter (thermocool, biosense webster), second-generation cryoballoon (arctic front advance, medtronic) were all used in this study.It is unknown which devices the patient has been used.Bwi takes conservative approach to report all the events occurred under thermocool, however catalog and lot number is unknown.

• Brand Name: UNK_THERMOCOOL SF NON NAV
• Type of Device: SIMILAR DEVICE D131501, PMA # P030031/S034
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7212586
• MDR Text Key: 98015978
• Report Number: 2029046-2018-01057
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NON NAV
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR