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

Model Number M0063903100

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a stone cone retrieval coil was returned for analysis.A visual evaluation found a part of the coil was detached and a burn mark at the break.The device opens and closes.Additionally, the handle was found broken into two pieces.The reported event that the device could not close could not be confirmed; however there is a burn mark at the break.The stone cone directions for use warns: do not directly fire upon the device with a laser.Therefore, the assigned complaint investigation conclusion code for this event is user / use error.Confirmed through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.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 was used in a rigid ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stone cone failed to straighten after it coiled.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patients' condition at the conclusion of the procedure was reported to be stable.This has been deemed an mdr reportable event based on investigation findings 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: 7906508
• MDR Text Key: 121714085
• Report Number: 3005099803-2018-02608
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 09/14/2018

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: 01/24/2021
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: 0004123922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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: 42 YR