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

Catalog Number UNK_THERMOCOOL SF NAV

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

Patient Problem Hematoma (1884)

Event Date 02/28/2017

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).(b)(4).

Event Description

This complaint is from a literature source.It was reported that one patient in the phenprocoumon group underwent left atrial radiofrequency ablation and developed a groin hematoma that required blood transfusion (2 erythrocyte concentrates) without the need for any further intervention.Title: ¿safety of uninterrupted periprocedural edoxaban versus phenprocoumon for patients who underwent left atrial catheter ablation procedures.¿ the purpose of this study was to compare the safety of uninterrupted edoxaban with uninterrupted phenprocoumon administration during larf ablation for atrial fibrillation and atrial tachycardia.The study was conducted from january 2016 to february 2017.231 patients were enrolled in this study.3.5-mm irrigated-tip thermocool sf rf ablation catheters were used in this study, however catalog and lot number were unknown.

• Brand Name: UNK_THERMOCOOL SF 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: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7385759
• MDR Text Key: 103970905
• Report Number: 2029046-2018-01379
• 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: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• 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): Other; Required Intervention
• Patient Age: 64 YR