MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS LOOP; STENT, URETERAL

Model Number	M0061552220
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral stent implantation procedure in the kidney, performed on (b)(6) 2021.During the procedure and inside the patient, when the physician attempted to implant the stent, it was noticed that the stent wrinkled.Another polaris loop stent was opened and successfully completed the procedure.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.
Additional Manufacturer Narrative
Block h6: medical device problem code a040601, captures the reportable event of stent buckled material inside the patient.Block h10: the returned polaris loop ureteral stent was analyzed.And a visual evaluation noted, that the bladder section buckled/accordion.The suture string was not return for the analysis.And the loops were in good shape.No other problems with the device were noted.The reported event was confirmed.According to product analysis, the device has the catheter buckled/accordion.The failure is known to be generated, due to an excess of force used when the stent is pushed up with the pusher/positioner over the guidewire.The device was received without the suture string and out of the original pouch.This is evidence that the device was handled.It is most likely, that it was generated, due to the manipulation of the device or due to the interaction with other devices, during the procedure.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed, that no anomalies or deviations related to the event occurred, during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation, that a polaris loop ureteral stent was used, during a ureteral stent implantation procedure in the kidney.Performed on (b)(6) 2021.During the procedure, and inside the patient.When the physician attempted to implant the stent, it was noticed, that the stent wrinkled.Another polaris loop stent was opened and successfully completed the procedure.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
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11649191
• Report Number: 3005099803-2021-01670
• Device Sequence Number: 3683196
• Product Code: FAD
• UDI-Device Identifier: 08714729421023
• UDI-Public: 08714729421023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: M0061552220
• Device Catalogue Number: 155-222
• Device Lot Number: 0025454720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70