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

Model Number	M0061921220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Premarket/510(k)# - k010002.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 ultra stent was used during a kidney stones removal surgery procedure in the kidney, performed on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the stent was broken along the shaft.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was used during a kidney stones removal surgery procedure in the kidney, performed on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the stent was broken along the shaft.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block f10; h6: problem code 1069 captures the reportable event of stent shaft break.Block g5: premarket/510(k)# - k010002.Block h10: a polaris ultra stent was returned for analysis.A visual evaluation of the returned device revealed that the shaft of the stent was detached.Based on the product analysis, the issue was noted during the procedure, moreover, no defects were reported by the customer during the unpacking and preparation.The reported issues observed in the provided images that could have been generated by user, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, "adverse event related to procedure" is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8739452
• Report Number: 3005099803-2019-03228
• Device Sequence Number: 16785598
• Product Code: FAD
• UDI-Device Identifier: 08714729124306
• UDI-Public: 08714729124306
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: 10/15/2021
• Device Model Number: M0061921220
• Device Catalogue Number: 192-122
• Device Lot Number: 0022802039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1