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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 Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental a will be filed.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the coil detached inside the patient and was successfully removed by using retrieval forceps.The sheath was also reported to be torn, and laser was reported to have been used during the procedure.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.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was used during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the coil detached inside the patient and was successfully removed by using retrieval forceps.The sheath was also reported to be torn, and laser was reported to have been used during the procedure.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
Initial reporter address 2 (b)(6).Device code 2907 captures the reportable event of coil detached.Mfr site address 1: industrial park j.,bermudez of cd juarez mfr site email: (b)(4).Investigation analysis a stone cone nitinol retrieval coil was returned for analysis.A visual evaluation of the returned device found that it was received open.The distal tip was detached from the device at the base of the coil.The wire appeared charred where the coil was detached.There was also a hole in the blue sheath.There was also charring on the edges of the hole in the sheath.Based on the condition of the device, it is likely that the failure mode seen was caused by laser damage.The dfu states "to minimize risk of device breakage or patient injury, do not fire laser directly on any part of the stone cone coil." based on the evidence of charring on both the sheath and the detached section of the coil it is likely that this device was damaged with direct laser firing.Therefore, the complaint investigation conclusion code for this complaint 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.Labeling review was performed and no anomalies were noted.
 
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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 Key8399259
MDR Text Key138101109
Report Number3005099803-2019-01090
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,distri
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/11/2021
Device Model NumberM0063903200
Device Catalogue Number390-320
Device Lot Number4406191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2019
Date Manufacturer Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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