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

Model Number M0063901050

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in a procedure performed on (b)(6) 2022.The device could not be used.Another zero tip basket was used to complete the procedure.There were no patient complications reported as a result of this event.The investigation results revealed the basket wire was detached.Therefore, this is now an mdr reportable event.

Manufacturer Narrative

(b)(4).The returned zero tip basket was analyzed, and a visual evaluation noted that the basket was in a open position when returned.One basket wire was detached from the knot and was not returned.Also, the sheath was bent at the distal end.Functional inspection found the basket will open and close normally.The reported event that the device could not be used was confirmed.Based on all available information, it is possible that operational factors such as excess of force applied, manipulation/interaction with other device or a stone, and possibly a cut with a sharp tool could have caused the issue found.Furthermore, sheath kinked could have been cause due to handing/manipulation, or interaction with other device.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14753916
• MDR Text Key: 294392124
• Report Number: 3005099803-2022-03422
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0028565051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1