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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE
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BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE Back to Search Results
Model Number M0063903200
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 urological retrieval coil was used in the ureter during a ureteroscopy procedure on an unknown date.According to the complainant, during the procedure, the coil was detached due to laser use.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
A stone cone retrieval coil was returned for analysis.A visual analysis revealed that the device was returned in two pieces.The coil was detached and returned.There are burn marks on the blue green shrink of both pieces indicating that the device was scorched.The condition of the returned device confirms the event.Since the device shows evidence of scorching which was caused by use of laser during the procedure, the assigned complaint investigation conclusion code for this event is caused by other device.The complaint investigation indicates another device/drug/subsequent procedure caused the complaint 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.A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a ureteroscopy procedure on an unknown date.According to the complainant, during the procedure, the coil was detached due to laser use.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
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Brand Name
STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
Type of Device
DISLODGER, STONE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7436819
MDR Text Key105779222
Report Number3005099803-2018-01197
Device Sequence Number1
Product Code FGO
UDI-Device Identifier08714729430223
UDI-Public08714729430223
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/29/2019
Device Model NumberM0063903200
Device Catalogue Number390-320
Device Lot NumberF78045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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