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

Model Number M0063901050

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  malfunction  

Event Description

Stone retrieval basket broke on the tip when it was being inserted during the removal of left ureteral and renal stones.Manufacturer response for zero tip nitinol stone retrieval basket, zero tip provided rga# and product return packaging.

Event Description

Stone retrieval basket broke on the tip when it was being inserted during the removal of left ureteral and renal stones.Manufacturer response for zero tip nitinol stone retrieval basket, zero tip provided rga# and product return packaging.

• 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: 10710831
• MDR Text Key: 212332033
• Report Number: 10710831
• 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
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 26014353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Weight: 88