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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE Back to Search Results
Model Number M0063903200
Device Problems Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a procedure for ureteral calculus removal performed on (b)(6) 2018.According to the complainant, during preparation, it was found that the coil coating was peeled off and the device would not open.The procedure was completed with another stone cone nitinol retrieval coil.There was no serious injury nor were there any adverse patient effects reported as a result of this event.
 
Manufacturer Narrative
Block g1 (mfr site address 2): industrial park j.,bermudez of cd juarez.Block g1 (mfr site email): (b)(4).Block h6: device problem code 1454 captures the reportable event of coil coating was peeled off.Block h10: a stone cone retrieval coil was returned for analysis.A visual analysis found the nitinol retrieval device was returned partially open.The blue sheath and white heat shrink are both accordioned.The nitinol core wire was also found kinked in several locations along the working length.The sheath is stuck halfway through the coil and will not open or close due to the damaged condition of the device.The reported event occurred prior to the procedure.It is likely that the user failed to follow the directions for use (dfu) by applying excessive force, resulting in the damaged sheath, core wire, and failure to open/close the coil.Therefore, the complaint investigation conclusion code selected is failure to follow instructions, which indicates that problems were traced to the user not following the manufacturer's instructions.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.A labeling review was performed and no anomalies were noted.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used in the ureter during a procedure for ureteral calculus removal performed on (b)(6) 2018.According to the complainant, during preparation, it was found that the coil coating was peeled off and the device would not open.The procedure was completed with another stone cone nitinol retrieval coil.There was no serious injury nor were there any adverse patient effects reported as a result of this event.
 
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Brand Name
STONE CONE
Type of Device
DISLODGER, STONE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8045735
MDR Text Key126658021
Report Number3005099803-2018-61258
Device Sequence Number1
Product Code FGO
UDI-Device Identifier08714729430223
UDI-Public08714729430223
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/16/2019
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 Date02/21/2021
Device Model NumberM0063903200
Device Catalogue Number390-320
Device Lot Number0004144675
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Initial Date Manufacturer Received 10/15/2018
Initial Date FDA Received11/07/2018
Supplement Dates Manufacturer Received12/23/2018
Supplement Dates FDA Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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