MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) URETERAL INDWELLING CATHETER/STENT; STENT, URETERAL

Model Number UNK92

Device Problem Calcified (1077)

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

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

Exact patient age unknown, however, it was reported that the patient's year of birth was 1967.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.Reported event of stent calcified.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a contour ureteral stent was implanted in the kidney/ureter on (b)(6) 2015 due to hydro nephrosis caused by ureter stone.Reportedly, the patient had no electrolyte imbalances.According to the complainant, during a planned stent removal procedure on (b)(6) 2015, the stent was "completely stuck" and could not be removed.The procedure was interrupted and an extra corporeal shockwave lithotripsy was performed and the stent was removed.Attempts to ascertain the patient铠condition following surgery have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: URETERAL INDWELLING CATHETER/STENT
• 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: 5096561
• MDR Text Key: 26512822
• Report Number: 3005099803-2015-02687
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK92
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• 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