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

Model Number M0061801560

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a contour vl¿ ureteral stent was implanted in the kidney during a stent placement procedure.According to the complainant, during the procedure, the retrieval suture was cut by the physician prior to placement of the stent.There were no issues with the stent or its placement approximately thirty days after placement, during the scheduled stent removal procedure, the patient went to the doctor¿s office to have the stent removed.However, the stent was unable to be removed by the physician in his office.Another procedure was scheduled to have the stent removed.A ureteroscopy was performed and found that the proximal end (renal coil) of the stent was tied in a knot.It was reported that the stent was not knotted when it was placed inside the patient, and it had been draining properly.The knotted stent was removed using stent graspers.Another stent did not need to be placed.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.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4) stent difficult to remove.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

• 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: 4302014
• MDR Text Key: 5055300
• Report Number: 3005099803-2014-03855
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M0061801560
• Device Catalogue Number: 180-156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention