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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 Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the coil detached into the patient.Percutaneous ureterolithotomy was performed to remove the detached coil.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
A visual analysis of the returned stone cone nitinol urological retrieval coil revealed that the cone of the device was returned broken in two pieces.Examination under magnification revealed light scorching on the cone at the break indicating that the break was caused by the holmium laser that was used to perform the procedure.Since the device shows evidence of scorching which was most likely caused by the laser during the ureteroscopy holmium laser lithotripsy procedure, the most probable root cause for this complaint event is caused by other.A search of the complaint database revealed that no similar complaints exist for the specified lot.The device history record (dhr) review found the device met all manufacturing specifications.A labeling review was performed and no anomaly was found.
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the coil detached into the patient.Percutaneous ureterolithotomy was performed to remove the detached coil.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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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 (Section G)
ACCELLENT ENDOSCOPY JUAREZ
31c butterfield trail
el paso TX 79906
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5849882
MDR Text Key51255540
Report Number3005099803-2016-02237
Device Sequence Number1
Product Code FGO
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2018
Device Model NumberM0063903200
Device Catalogue Number390-320
Device Lot NumberD62506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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