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

Model Number	M0061552220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
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 stent was unpacked for use for a ureteral drainage procedure to be performed in the bladder for urologic obstruction on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the stent was fractured.The procedure was completed using another polaris loop stent.There were no patient complications as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
(b)(4).A polaris loop stent was returned for evaluation.A visual evaluation of the returned device found that the proximal section of the stent was damaged, both loops were broken.No other anomalies were noted.Based on the product analysis, it is most likely that the stent has been damaged due to some handling aspect; thereby, causing the damage found (loop detached or broken).The loop of the stent was likely detached or broken by the suture, the failure found is consistent with one caused when suture is being pulled with excess of force and the damage was noted at the bladder side of the device specifically in the loop where the suture goes placed.Therefore, 'cause traced to component failure' 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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop stent was unpacked for use for a ureteral drainage procedure to be performed in the bladder for urologic obstruction on (b)(6) 2018.According to the complainant, during unpacking, it was noticed that the stent was fractured.The procedure was completed using another polaris loop stent.There were no patient complications as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8122305
• Report Number: 3005099803-2018-61712
• Device Sequence Number: 13845239
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2018

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: 04/09/2021
• Device Model Number: M0061552220
• Device Catalogue Number: 155-222
• Device Lot Number: 0021971726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 62