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

Model Number M0061801560

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) a visual analysis of the device found that the stent was broken at the middle and its suture was not returned.The evaluation concluded that the most probable root cause for this event is related to the way the device was handled and manipulated during unpacking or preparation which could have contributed to the failure noted.The most probable cause is considered 'handling damage.' a review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a contour vl ureteral stent was used during a ureteroscopy procedure performed in the ureter on (b)(6) 2015.According to the complainant, during preparation, when the physician went to pick the stent to be placed in the patient, the stent crumbled and broke apart.Reportedly, they were unsure if it was the coil that detached.The procedure was completed with another contour vl ureteral stent.Attempts to ascertain the patient's condition following surgery have been unsuccessful.Investigation results revealed the stent broke, therefore this event has been deemed an mdr reportable event.

• Brand Name: CONTOUR VL¿
• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5267973
• MDR Text Key: 32714691
• Report Number: 3005099803-2015-03585
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2015

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: Physician
• Device Expiration Date: 03/04/2018
• Device Model Number: M0061801560
• Device Catalogue Number: 180-156
• Device Lot Number: 17744767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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