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

Model Number M0061456130

Device Problems Calcified (1077); Difficult to Remove (1528)

Patient Problem Unspecified Infection (1930)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

Device code relates to problem code for the reported event of stent difficult to remove.Device code relates to problem code for the reported event of stent calcified.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an ascerta¿ ureteral stent that was previously implanted in the ureter approximately 1 month prior to the stent removal procedure performed on (b)(6) 2015.Reportedly, about a month prior to the stent removal procedure, and after the stent was implanted, it was observed that the bloody urine has not improved and the physician thought that an infection has developed due to the presence of cloudy urine.Thus, they decided to remove the stent.According to the complainant, the patient was noted to have "bloody urine" and the ascerta¿ ureteral stent was implanted to treat this condition.There was no issue noted to the device during the stent placement procedure.After the stent placement, (exact timeframe unknown) drainage was bad and the patient urine was noted to be cloudy, therefore the physician decided to remove the stent and place a new stent.Reportedly, the physician had planned to remove the stent "sooner than one month".During the stent removal procedure on (b)(6) 2015, the guidewire would only advance to the middle of the stent due to an occlusion suspected caused by the bloody urine or a possible infection.Due to the occlusion, the physician decided to attempt removing the stent with forceps.However, the pigtail of the stent could not be straightened.The removal of the stent was not completed due to this event.Open surgery was performed to remove the stent on (b)(6) 2015.The stent was removed successfully from the patient, and the stent was noted to be calcified.There were no patient complications as a result of this event and the current condition of the patient was reported to be stable.

• Brand Name: ASCERTA¿
• 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: 5000834
• MDR Text Key: 22876712
• Report Number: 3005099803-2015-02280
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/17/2015

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: Health Professional
• Device Expiration Date: 01/29/2017
• Device Model Number: M0061456130
• Device Catalogue Number: 145-613
• Device Lot Number: 17631055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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
• Patient Outcome(s): Required Intervention