MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) POLARIS¿ ULTRA; STENT, URETERAL

Model Number M0061921330

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

(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 polaris¿ ultra stent was used in the bladder during a ureteroscopy procedure on (b)(6) 2017.According to the complainant, during procedure, the physician moved the stent using a grasper it was noted that the stent broke at the end of the bladder coil.The stent was completely removed from the patient and the procedure was completed with another of the same device.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

A visual analysis of the returned device revealed that the stent was broken at the bladder pigtail; also the suture hole was torn.The suture was not returned, moreover, the section broken was inspected under magnification, and evidence of torsion was noted.There is no evidence of material degradation.Based on product analysis, most likely there was some anatomical/procedural factors that were encountered during the procedure which may have limited the overall performance of the device.The failure found could have been caused by the use of the grasper during the stent removal; in addition, the device also had the suture hole torn, which is a failure that is consistent with one caused by the suture when it is being pulled during the procedure.Therefore, the most probable root cause of this complaint is operational context.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.A review of the device history record (dhr) was performed and no anomalies were noted.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and no anomaly was found.

Event Description

It was reported to boston scientific corporation that a polaris ultra stent was used in the bladder during a ureteroscopy procedure on (b)(6) 2017.According to the complainant, during procedure, the physician moved the stent using a grasper it was noted that the stent broke at the end of the bladder coil.The stent was completely removed from the patient and the procedure was completed with another of the same device.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: POLARIS¿ ULTRA
• 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: 7033440
• MDR Text Key: 92074770
• Report Number: 3005099803-2017-03394
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 20812089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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