MAUDE Adverse Event Report: BOSTON SCIENTIFIC STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE

Model Number M0063903100

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/17/2015

Event Type  Injury  

Event Description

Stone cone device detached resulting in unintended retention of foreign body in the pt's right ureter.This detachment was not discovered initially.During post-surgical f/u pt stated an umbrella like device which appeared to be made of cellophane passed through his urethra approx 2 weeks post-op.Ct scan revealed foreign body in the right ureter.Unable to remove the foreign body ureteroscopically.The pt required surgical intervention resulting in the removal of 2 mildly encrusted fragments of stone cone.

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5836222
• MDR Text Key: 50914826
• Report Number: MW5063754
• Device Sequence Number: 1
• Product Code: FGO
• 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: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR