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

Model Number M006390150

Device Problems Difficult to Open or Close (2921); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation analysis: a zero tip basket was returned for analysis.A visual evaluation of the returned device revealed that the sheath was damaged.The basket was in closed/retracted position when received.The sheath was found torn approximately at 5.4 cm from the distal end.The sheath was kinked in several locations at the distal end.The handle was actuated, however the basket was not able to open due to the device condition (sheath torn).The distal section of the sheath (after torn area) was removed in order to inspect the basket.It was observed that the basket was not bent.The reported issue of basket bent could not be confirmed, and will be documented as "no problem detected", since the device complaint or problem could not be confirmed.The failures found (sheath torn/kinked), are issues that could have been generated due to manipulation of the device during its use, the interaction with the scope or interacting with other devices could have contributed to kinking of the sheath.Once the sheath is severely kinked the inner diameter of it would be reduced in kinked areas which can cause issues to extend the basket.Continued attempts to extend the basket can lead to tearing of the sheath.Based on the information available and the analysis performed, the investigation conclusion code for the encountered issues will be documented as "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a zero tip basket was to be used in a procedure involving cystoscopy, ureteroscopy, laser lithotripsy, and stone extraction with stent placement performed on (b)(6) 2019.According to the complainant, during preparation, the tip of the basket was noticed to be bent.The procedure was completed with another zero tip basket.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results of sheath found torn at the distal end.

• 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: 8503928
• MDR Text Key: 141600967
• Report Number: 3005099803-2019-01860
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2021
• Device Model Number: M006390150
• Device Catalogue Number: 390-105
• Device Lot Number: 23215900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2019
• 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