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

Model Number M0063901050

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Patient underwent lithotripsy procedure with stone removal.Patient returned approximately one year later for removal of retained foreign body.During the removal of the foreign body, a nitinol basket was identified within the renal pelvis with large stone attached.The following biliary/urinary stone retrieval baskets were used during the original surgical procedure: boston scientific zero tip nitinol stone retrieval basket 1.9f x 120cm (ref#m0063901050) and cook medical perc ncircle nitinol tipless stone extractor 10f x38cm (refg32862).

• Brand Name: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13314109
• MDR Text Key: 284195137
• Report Number: 13314109
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M0063901050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2022
• Date Report to Manufacturer: 01/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19345 DA