MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-00

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 12/31/2015

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.Concomitant products that used in this study: carto system, lasso catheter.Other company¿s devices that were used in this study: diagnostic ultrasound catheter (5.5¿10 mhz,8f, acunav, siemens medical), navx (st.Jude medical).(b)(4).The devices were not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 1 patient with prior mitral valve surgery underwent radiofrequency catheter ablation for symptomatic atrial arrhythmias and suffered retroperitoneal hematoma requiring surgery.Additional information was obtained from author: bwi device cited in the article did not lead to the reported patient consequences.Physician stated that the causality of adverse event was procedure-related.The catheters used in this procedure were not reprocessed / reused catheters.Retroperitoneal hematoma event did not result in the impairment of a body function or damage to a body structure.(b)(6) female ((b)(6) pounds) patient who had retroperitoneal bleeding continued bleed from small branch of artery requiring surgery and stenting.She was in the hospital for a prolonged time and needed transfusion but otherwise recovered with no long term sequelae.Title: ¿postoperative atrial tachycardias after mitral valve surgery: mechanisms and outcomes of catheter ablation.¿ the purpose of this study was to determine the electrophysiological mechanisms of at in patients with prior mv surgery and the long-term outcomes of catheter ablation.Sixty seven patients were enrolled in this study between january 2007 and december 2015.Suspect device is 3.5-mm irrigated-tip thermocool ablation catheter, however catalog and lot number are unknown.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6307469
• MDR Text Key: 66715963
• Report Number: 9673241-2017-00097
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2017

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-1336-00
• Device Catalogue Number: D133600
• Device Lot Number: UNKNOWN_D-1336-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/07/2017
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82