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

Model Number M0061802230

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a contour¿ ureteral stent was used during a ureteroscopy procedure performed in the ureter on (b)(6) 2015.According to the complainant, during the procedure, the stent pigtails would not curl when deployed in the kidney.The physician tried to manipulate it to get it to curl but it kept straight.Under x-ray, the stent was found linear in shape and when it was removed, it appeared relaxed.The procedure was completed with another contour stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Reported event of "stent would curl." 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.

Manufacturer Narrative

(b)(4).A visual analysis found no anomalies or damage to the device.Dimensional inspection of the stent's working length was performed and found that it is within specification.During functional analysis, a 0.038 mandrel was inserted and it passed properly without resistance; both coils formed without any problem when the guidewire was removed.The complaint that the stent did not curl was not confirmed.The device showed no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a contour ureteral stent was used during a ureteroscopy procedure performed in the ureter on (b)(6) 2015.According to the complainant, during the procedure, the stent pigtails would not curl when deployed in the kidney.The physician tried to manipulate it to get it to curl but it kept straight.Under x-ray, the stent was found linear in shape and when it was removed, it appeared relaxed.The procedure was completed with another contour stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: CONTOUR?
• 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: 4849452
• MDR Text Key: 5939992
• Report Number: 3005099803-2015-01596
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/27/2017
• Device Model Number: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 17222529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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 Age: 84 YR