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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
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.
 
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Brand NameZERO TIP
Type of DeviceDISLODGER, 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 Key8503928
MDR Text Key141600967
Report Number3005099803-2019-01860
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729469643
UDI-Public08714729469643
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2021
Device Model NumberM006390150
Device Catalogue Number390-105
Device Lot Number23215900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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