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

Model Number	M0061458620
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(b)(4).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.
Event or Problem Description
It was reported to boston scientific corporation that a suredrive tm was removed in a ureteral stent removal procedure performed on (b)(6) 2017.According to the complainant, the stent was previously implanted in (b)(6).The exact date of implantation is unknown.When removal was started, the physician noticed that the kidney side coil was not deployed straight and it was pulled out in u-shape.The stent was completely removed by being grasped with forceps under cystoscope.There were no patient complications reported as a result of this event.

• Brand Name: SUREDRIVE TM
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7104021
• Report Number: 3005099803-2017-03678
• Device Sequence Number: 1933397
• Product Code: FAD
• UDI-Device Identifier: 08714729903178
• UDI-Public: 08714729903178
• Combination Product (Y/N): N
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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
• Operator of Device: Health Professional
• Device Model Number: M0061458620
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1