MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE

Model Number	M0063903100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual analysis of the returned device found the device was returned in one piece.The core wire pulled out when trying to close the device.Furthermore, the core wire was broken into two pieces.The blue sheath and white heat shrink were found accordion.Moreover, the white shrink was torn.In addition, the blue/ green shrink was pulled away from distal stop.Evaluation concluded that the broken core wire most likely caused by the lithotripter during the procedure.Therefore, the most probable root cause for this complaint event is caused by other device.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a ureterolithotomy procedure on (b)(6) 2017.According to the complainant, during the procedure, the handle end of the blue sheath accordioned when attempting to close the device.The coil failed to close and there was difficulty removing the device from the ureter.Device was disassembled and was removed from the patient.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.This event has been deemed a reportable event based on the investigation results; core wire broken.

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6649024
• Report Number: 3005099803-2017-01763
• Device Sequence Number: 19113228
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: (01)08714729430209(17)20180430(10)D86221
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2017

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
• Operator of Device: Health Professional
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: D86221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR