MAUDE Adverse Event Report: COOK UROLOGICAL INC. ATLAS WIRE STONE EXTRACTOR

Model Number AE-428115

Device Problem Separation Failure (2547)

Patient Problems Extravasation (1842); Injury (2348)

Event Date 03/22/2015

Event Type  Injury  

Event Description

An attempt at placing a 3 french, 4 wire basket around the distal aspect of the stone was able to engage the stone itself and slightly dislodge the stone inferiorly, however, it was clearly impacted against the side wall of the ureter.Therefore, i then attempted to disengage the stone basket; however, the stone basket failed and would not disengage.Multiple attempts at disengagement were tried.Therefore, the matter of recourse was to cut the stone basket wire proximal to the control handle.Several wires which navigated the stone were then sequentially cut until the basket did disengage.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 patient was taken to the recovery room in satisfactory condition.Patient was in operating room under general anesthesia when event occurred.

• Brand Name: ATLAS WIRE STONE EXTRACTOR
• Type of Device: ATLAS WIRE STONE EXTRACTOR
• Manufacturer (Section D): COOK UROLOGICAL INC.; spencer IN 47460
• MDR Report Key: 4643441
• MDR Text Key: 5755437
• Report Number: MW5041692
• Device Sequence Number: 1
• Product Code: FFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: AE-428115
• Device Catalogue Number: OPN REF G32788
• Device Lot Number: U2423719
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 125