MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CONTOUR?; STENT, URETERAL

Model Number M0061802330

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a contour ureteral stent was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2014.According to the complainant, during the procedure inside the patient, the contour stent kinked or folded up on itself at the back end.The procedure was completed with another of the same device.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 fine.This event has been deemed a reportable event based on the investigation results; bladder pigtail was damaged.

Manufacturer Narrative

A visual analysis on the returned contour ureteral stent was performed and it was noted that the bladder pigtail was damaged, and the suture was not returned.A mandrel was inserted through the stent and it passed properly without resistance.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.Therefore, taking into consideration these factors and the analysis performed on the returned device, the most probable root cause is "operational context".

• Brand Name: CONTOUR?
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3969947
• MDR Text Key: 4626290
• Report Number: 3005099803-2014-02692
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/30/2017
• Device Model Number: M0061802330
• Device Catalogue Number: 180-233
• Device Lot Number: 16833198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• 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: 72 YR