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

Model Number M0063903100

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

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 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
• 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 Key: 6649024
• MDR Text Key: 77834268
• Report Number: 3005099803-2017-01763
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: (01)08714729430209(17)20180430(10)D86221
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR