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

Model Number M0061458620

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

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 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
• 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: 7104021
• MDR Text Key: 94496293
• Report Number: 3005099803-2017-03678
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729903178
• UDI-Public: 08714729903178
• 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
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M0061458620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/11/2017
• 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