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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATLAS WIRE FLAT WIRE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL

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ATLAS WIRE FLAT WIRE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Catalog Number AE-428115
Device Problem Separation Failure (2547)
Patient Problems Extravasation (1842); No Code Available (3191)
Event Date 03/23/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4): the wires in the stone basket had to be cut, so the basket would disengage). The reported information was received from mw5041692. This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
The following information was reported: a 3 french, 4 wire basket was placed around the distal aspect of the stone during a ureteroscopy. The stone was engaged and slightly dislodged inferiorly, but it was clearly impacted against the side wall of the ureter. As a result, there was an attempt to disengage the stone basket, but the stone basket failed and would not disengage. Multiple attempts at disengagement were tried. The matter of recourse was to cut the stone basket wire proximal to the control handle. Several wires that navigated the stone were then sequentially cut until the basket disengaged. Due to the necessary tension applied to the stone basket to manually disengage it in the above mentioned manner, there clearly was some mild trauma to the ureteral wall and mucosa. A retrograde showed some extravasation. Several attempts at repeat guidewire placement up the ureter were unsuccessful and the bladder was then drained. The device was fully removed from the patient and the patient was taken to the recovery room in satisfactory condition. The patient was in operating room under general anesthesia when event occurred. Based upon the information received, there was no report of the patient requiring any additional procedures as a result of this occurrence.
 
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Brand NameATLAS WIRE FLAT WIRE EXTRACTOR
Type of DeviceFFL DISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7135689
MDR Text Key95451751
Report Number1820334-2017-04110
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAE-428115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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