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).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 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 october.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.

Manufacturer Narrative

A visual evaluation of the returned device found that it was damaged (accordioned) at the bladder pigtail and residues were noted on the stent.Both coils were found correctly formed.Moreover, the event was reported to have occurred during device withdrawal and inside the patient; in addition, the failure noted (device accordioned) is a known failure generated when the guidewire is pulled or pushed with excess of force through the stent.Therefore, the most probable root cause of this complaint is operational context, since it is most likely that due to anatomical and/or procedural factors encountered during the device introduction, performance was limited.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

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 october.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: 7107945
• MDR Text Key: 95066656
• Report Number: 3005099803-2017-03676
• 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,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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