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

Model Number M0061552320

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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¿ loop stent was implanted on (b)(6) 2017, for a ureteroscopic lithotripsy (urs) procedure performed in the kidney, ureter, and bladder.According to the complainant, post procedure on (b)(6) 2017 the patient felt severe pain.Xray was performed and revealed that the stent had advanced into the ureter and the kidney coil which was deployed at the upj.Moreover it had advanced towards the upper pole of the kidney.The distance noticed was approximately 2 cm.The entire stent was removed with a reusable grasper.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 stable.

Manufacturer Narrative

A visual analysis of the returned device revealed that the loops on the stent were returned tangled and no other anomalies or damages were found.A functional evaluation was performed, and revealed that a mandrel 0.038 inches was inserted through the stent, and it passed through properly without resistance.Based on the information available regarding the event description, and taking into account that the failures that were reported (stent migrated and patient discomfort/pain) are in the dfu noted as adverse events, the most probable cause for this complaint is anticipated procedural complication, since it is most likely that the complaint was due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.Moreover, the device returned was found with both loops tangled, so it is most likely that they were tangled due to the stent migration that was reported; however, it is important to mention that after visual inspection the loops were straightened and no damages were noted to the device.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 revealed 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 loop stent was implanted during a ureteroscopic lithotripsy (urs) procedure performed in the kidney, ureter, and bladder.According to the complainant on (b)(6) 2017, approximately a week post procedure, the patient felt severe pain.X-ray was performed and revealed that the stent had advanced into the ureter, and the kidney coil which was deployed at the upj had advanced towards the upper pole of the kidney.The stent had migrated up a distance of approximately 2cm.The entire stent was removed using a reusable grasper prior to the planned removal procedure due to the migration and severe pain.The distal loop portion of the stent appeared to be knotted.The entire stent was removed intact, and no parts remained in the patient.The procedure was completed, and a replacement stent was not needed.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 stable.

Event Description

It was reported to boston scientific corporation that a polaris loop stent was implanted during a ureteroscopic lithotripsy (urs) procedure performed in the kidney, ureter, and bladder.According to the complainant on (b)(6) 2017, approximately a week post procedure, the patient felt severe pain.X-ray was performed and revealed that the stent had advanced into the ureter, and the kidney coil which was deployed at the upj had advanced towards the upper pole of the kidney.The stent had migrated up a distance of approximately 2cm.The entire stent was removed using a reusable grasper prior to the planned removal procedure due to the migration and severe pain.The distal loop portion of the stent appeared to be knotted.The entire stent was removed intact, and no parts remained in the patient.The procedure was completed, and a replacement stent was not needed.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 stable.

• Brand Name: POLARIS¿ LOOP
• 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: 7033450
• MDR Text Key: 92074752
• Report Number: 3005099803-2017-03504
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: 08714729421085
• Combination Product (y/n): N
• PMA/PMN Number: K030503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2017

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: 10/03/2019
• Device Model Number: M0061552320
• Device Catalogue Number: 155-232
• Device Lot Number: 19783044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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 Outcome(s): Required Intervention