MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP NITINOL STONE RETRIEVAL BASKET; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number MOO63901050

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2019

Event Type  Injury  

Event Description

Unable to release the boston scientific aero tip stone retrieval basket during ureteroscopy.Basket was gently pulled on with constant pressure and broke in the middle of the basket shaft in the upper ureter.Attempted to retrieve with a grasper but unsuccessful.Laser 2 sides of the basket to release from stone and attempted to rasp again without success.Basket parts retrieved during right percutaneous nephrolithotomy.

• Brand Name: ZERO TIP NITINOL STONE RETRIEVAL BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 9369066
• MDR Text Key: 167978189
• Report Number: MW5091277
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MOO63901050
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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: 58 YR
• Patient Weight: 117