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

Model Number	M006155232090
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the device was found without any problems.The returned device was found with loops in a good condition; no other issues (kinks, bends, torn or detached) were found in the device.Also, the suture string returned in a good condition, the positioner and the stabilizer were returned in a good shape.A mandrel 0.035" was loaded in the device and no resistance was felt.Additionally, before the decontamination process, the returned device was inspected and no foreign matter was noticed.No other problems with the device were noted.The reported event of packaging foreign matter was not confirmed.Based on the event description and information gathered from the customer, there is no enough evidence to determine whether the packaging foreign matter was due to the physician's technique or the procedural and anatomical conditions during the reported event, or whether it was related to a device malfunction during the procedure.Review and analysis of all available information indicated that the root cause of the problems found is cause not established is selected as the most probable 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 ultra ureteral stent was opened to be used during a stent replacement procedure performed on (b)(6) 2021.During the procedure, outside of the patient a hair or some short thread was found within the package.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 as "no patient injury".

• 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: 12453220
• Report Number: 3005099803-2021-04651
• Device Sequence Number: 19127794
• Product Code: FAD
• UDI-Device Identifier: 08714729765516
• UDI-Public: 08714729765516
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: 02/12/2024
• Device Model Number: M006155232090
• Device Catalogue Number: 155-232-09
• Device Lot Number: 0027126380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1