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

Model Number M006192132090

Device Problems Bent (1059); Kinked (1339); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and the expiration date are unknown.However, the complainant reported that the device was not expired.(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 removed from the ureter, during a planned ureteral stent removal procedure performed on (b)(6) 2018.It was reported that the stent was implanted for about two weeks prior to removal.The stent was previously implanted as pretreatment for a procedure on the upside ureter stone.According to the complainant, during the removal procedure, the physician noticed on x ray that the stent appeared to be kinked and torn.The stent was reported to have ripped during removal.The entire stent was removed.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 ¿no complication¿.

Manufacturer Narrative

A polaris ultra was received for analysis.A visual analysis of the returned device, found that the stent was ripped/torn at 4.5cm from the bladder pigtail proximal section.No other anomalies were noted.The complaint of the stent being ripped/torn was confirmed.It is most likely that during the procedure the device could have been manipulated, since the failures found are issues that could have been generated by excessive manipulation of the device by the user, also interaction with other devices might have impacted the integrity of the device.Therefore the most probable cause of this complaint is operational context, probably due to anatomical/procedural factors encountered during the procedure, performance was limited.

Event Description

It was reported to boston scientific corporation that a polaris ultra stent was removed from the ureter, during a planned ureteral stent removal procedure performed on (b)(6) 2018.It was reported that the stent was implanted for about two weeks prior to removal.The stent was previously implanted as pretreatment for a procedure on the upside ureter stone.According to the complainant, during the removal procedure, the physician noticed on x ray that the stent appeared to be kinked and torn.The stent was reported to have ripped during removal.The entire stent was removed.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 ¿no complication¿.

• 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: 7449233
• MDR Text Key: 106151944
• Report Number: 3005099803-2018-01215
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124436
• UDI-Public: 08714729124436
• Combination Product (y/n): N
• PMA/PMN Number: K010002
• 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: 04/02/2018

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: M006192132090
• Device Catalogue Number: 192-132-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 06/04/2018
• 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