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

Model Number	M0063903100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual analysis of the returned stone cone nitinol urological retrieval coil revealed that the device returned stuck in the close position, hence, the device will not open.The distal portion of the device, just above the distal stop is missing and was not returned.The condition of the returned device confirms the event.Due to anatomical and/or procedural factors encountered during the procedure, performance was limited.Therefore, the most probable root cause of this complaint is operational context.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval was used during a ureteroscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the device was positioned in the ureter, however, the device failed to open.The device was then removed from the ureter.The procedure was completed with another stone cone nitinol urological retrieval.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 an mdr-reportable event based on investigation results which revealed that the coil/cone detached or separated.

• 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: 6293416
• Report Number: 3005099803-2017-00237
• Device Sequence Number: 19083174
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: (01)08714729430209(17)20190512(10)F35089
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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): 01/11/2017

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 Expiration Date: 05/12/2019
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: F35089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1