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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ESCAPE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063902010
Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Visual inspection of the returned device found that the shrink tube section was kinked/bent. The handle was disassembled to inspect the internal components; and it was found that the sheath was torn and buckled inside the shrink tube, and the pull was broken. The broken ends were inspected under magnification and it was observed that there was kinking on both broken ends. Therefore, the customer complaint of the pull wire being bent was confirmed. Based on all available information, it is most likely that handling and manipulation of the device during its use could have kinked the device at the proximal section. Operational factors, such as user technique while removing the device from its tray, could have kinked the device. Once it is kinked, it can cause friction between the components during the handle actuation. Continued attempts to extend/retract the basket can tear and buckle the sheath and force to actuate the device could have resulted in breakage on where the pull wire was kinked. Therefore, the most probable root cause is adverse event related to procedure. A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
 
Event Description
It was reported to boston scientific corporation that an escape basket was used in urinary tract during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2020. According to the complainant, when the device was unpacked, the working length pull wire was found to be bent and the basket could not be opened or closed. The procedure was completed with another escape basket. There were no patient complications reported as a result of this event. The patient's condition post procedure was reported to be stable. The investigation results revealed that the pull wire was broken; therefore, this is now an mdr reportable event.
 
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Brand NameESCAPE
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 Key10864260
MDR Text Key225874746
Report Number3005099803-2020-05317
Device Sequence Number1
Product Code FFL
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 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063902010
Device Catalogue Number390-201
Device Lot Number0025242938
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2020
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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