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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 06/09/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy (urs) procedure in the ureter performed on (b)(6) 2014.According to the complainant, during preparation after soaking the device in saline, the tip of the stone cone coil broke and detached before inserting it into the working channel of the scope.The tip broke when the nurse tried to close the device in order to insert it into the scope.The procedure was completed with another of the same 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 good.
 
Manufacturer Narrative
Reported event of tip detachment.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.
 
Manufacturer Narrative
Visual analysis on the returned stone cone nitinol urological retrieval coil was performed and revealed that the distal stop and distal tip were missing and were not returned.The device opened and closed with extreme resistance.The blue/green heat shrink/core wire was broken at the distal end of the cone, and the blue/green heat shrink was scorched, which appeared to be burned, at the distal end.Analysis also revealed that the cone was seemed to be stretched with very high force.The device history record (dhr) review found that the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.During manufacturing, the devices are 100% inspected for functionality / integrity.Therefore, taking into consideration these factors and the analysis performed on the returned device, the most probable root cause is "undeterminable".
 
Event Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used during a ureteroscopy (urs) procedure in the ureter performed on (b)(6) 2014.According to the complainant, during preparation after soaking the device in saline, the tip of the stone cone coil broke and detached before inserting it into the working channel of the scope.The tip broke when the nurse tried to close the device in order to insert it into the scope.The procedure was completed with another of the same 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 good.
 
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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 Key3909649
MDR Text Key4521318
Report Number3005099803-2014-02475
Device Sequence Number1
Product Code FGO
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/10/2014
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 Date03/31/2017
Device Model NumberM0063903200
Device Catalogue Number390-320
Device Lot NumberC28950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/26/2014
Initial Date FDA Received07/02/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2014
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 Age56 YR
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