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

Model Number M0063903200

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A stone cone nitinol retrieval coil was received for analysis.A visual analysis of the returned device, found that the blue sheath overrode the distal stop.As a result, the device is stuck closed and will not open.The blue/green heat shrink is pulled away from the distal stop.The condition of the returned device confirms the event of device won¿t open.The sheath most likely overrode the distal stop during preparation and outside the patient.Therefore the most probable root cause is ¿handling damage".The complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during introduction, the coil failed to opened.The procedure was completed with another stone cone.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; stone cone retrieval coil coating peeled/shared/frayed.

• 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 Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7477963
• MDR Text Key: 107193167
• Report Number: 3005099803-2018-01159
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 02/28/2018

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 Date: 07/10/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0003809705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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