MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR RMT 4MM; SIMILAR DEVICE NR7TCSIY, PMA # P030031

Catalog Number UNK_NAVISTAR RMT 4MM

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

Patient Problem Thrombosis (2100)

Event Date 10/31/2006

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 companies devices that used in this study: niobe stereotaxis mns (stereotaxis, inc, (b)(4)).(b)(4).

Event Description

This complaint is from a literature source.It was reported that one (b)(6) patient (patient #23) with scar-related ventricular tachycardia (vt) underwent radiofrequency ablation and developed uncomplicated bilateral lower-extremity deep venous thrombosis that was successfully treated with anticoagulation.Patient's medical history includes incessant monomorphic vt, icd storm.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: ¿remote magnetic navigation to guide endocardial and epicardial catheter mapping of scar-related ventricular tachycardia¿ the purpose of this study to examine the safety and feasibility of using a remote magnetic navigation system to perform endocardial and epicardial substrate-based mapping and radiofrequency ablation in patients with scar-related ventricular tachycardia.The study was conducted between november 2005 and october 2006.Suspect devices are remotely guided, 4-mm-tip, navistar quadripolar (rmt) catheter, however catalog and lot number is unknown.

• Brand Name: NAVISTAR RMT 4MM
• Type of Device: SIMILAR DEVICE NR7TCSIY, PMA # P030031
• 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 ; 909838-723
• MDR Report Key: 7077210
• MDR Text Key: 93559080
• Report Number: 2029046-2017-01221
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2017

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 Catalogue Number: UNK_NAVISTAR RMT 4MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/01/2017
• 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 Age: 62 YR