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

Model Number UNK323

Device Problems Bent (1059); Calcified (1077); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a polaris loop stent was used during a stent removal procedure in the ureter.According to the complainant, during procedure, it was noticed that the renal side of the pigtail was bent, making it difficult to remove.It was also noticed that the stent was calcified.To remove the stent, transurethral lithotripsy (tul) was performed.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that a polaris loop stent was used during a stent removal procedure in the ureter.According to the complainant, during procedure, it was noticed that the renal side of the pigtail was bent, making it difficult to remove.It was also noticed that the stent was calcified.To remove the stent, transurethral lithotripsy (tul) was performed.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: MODIFICATION TO CONTOUR POLARIS URETERAL 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: 7364758
• MDR Text Key: 103267013
• Report Number: 3005099803-2018-00910
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K030503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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 Model Number: UNK323
• Device Catalogue Number: 192-132-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 03/28/2018
• 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