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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 M0063901020
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2019
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(6). (b)(4). Visual analysis of the returned device found the sheath torn at proximal and distal section and kinked in several locations. One section of the sheath is still on the device, but the rest of the sheath was removed. The basket assembly was detached from the device and it was not returned for analysis. The device showed excessive manipulation, as it was severely damaged. It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity. Handling and manipulation of the device during its use can lead to the kinking of the sheath in several locations; also interaction with the scope could have contributed with the encountered damages. Once the sheath is kinked at the distal end, this condition would cause friction between the sheath and the inner wire during the handle actuation at kinked areas, and continued attempts to open/close the basket or too much force applied to the handle can result in the tearing of the sheath and basket assembly detachment. The directions for use states "precaution: kinks in the sheath will hinder the mechanical operation of the basket. " during its manufacturing process the product is inspected for functionality and integrity, however there is no control in how the units are handled during the procedure. Based on the information available and the analysis performed, the most likely root cause for the complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event. A manufacturing batch record review was unable to be performed as the lot number is unknown. However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
 
Event Description
It was reported to boston scientific corporation that a zero tip retrieval basket was used in a procedure performed on an unknown date. According to the complainant, the device was unable to open and close. The procedure completed with the another zero tip basket. There were no patient complications as a result of this event. Investigation results revealed that the sheath torn at distal end and basket detached; therefore, this is now an mdr reportable event.
 
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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 Key8903146
MDR Text Key154638112
Report Number3005099803-2019-04061
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729342014
UDI-Public08714729342014
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063901020
Device Catalogue Number390-102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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