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

Model Number	M0061921550
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0414 captures the reportable event of stent torn, inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during an angiography procedure in the right ureter performed on (b)(6) 2023.During the procedure, it was noted that when they tried to remove the suture, the coil of the stent was hurt.The procedure was successfully completed with another polaris ultra ureteral 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 "good".A photo of the complaint device was provided and showed that the distal end of the stent was ripped/torn.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn, inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the suture hole was torn until the tip.The stent pigtail was observed buckled accordioned.Functional test uses a mandrel noted that it passes through the stent successfully, no felt resistance.During a magnification, the found issues was observed closely.Moreover, it was observed that a side port hole occluded and some residues as part of the procedure.No other problem with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.If the suture string or retrieval line is intended to be removed before procedure, the line may be removed before stent placement.The retrieval line may be cut prior to stent placement.Remove the retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull out the retrieval line.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions.Since problem is traced to the user not following the manufacturers instructions.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 ultra ureteral stent was used during an angiography procedure in the right ureter performed on (b)(6) 2023.During the procedure, it was noted that when they tried to remove the suture, the coil of the stent was hurt.The procedure was successfully completed with another polaris ultra ureteral 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 "good".A photo of the complaint device was provided and showed that the distal end of the stent was ripped/torn.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16525863
• Report Number: 3005099803-2023-01270
• Device Sequence Number: 14114593
• Product Code: FAD
• UDI-Device Identifier: 08714729124726
• UDI-Public: 08714729124726
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 08/03/2025
• Device Model Number: M0061921550
• Device Catalogue Number: 192-155
• Device Lot Number: 0029886667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male