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

Model Number	M006193131090
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(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 ultra stent was to be used in a procedure performed on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the packaging of a polaris ultra stent was open and the sterility of the device was compromised.The procedure was successfully completed with another polaris ultra stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
The device was returned with its original opened pouch.A visual analysis of the retuned opened pouch found that the sealed marks were evidence that the selaed procesds was properly performed.No visual defects were observed on the stent and the pouch.Basd on product analysis, and all compiled information, the most probable cause of this event is no problem detected since the complaint included a returned device review (visual, physical, and performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.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 ultra stent was to be used in a procedure performed on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the packaging of a polaris ultra stent was open and the sterility of the device was compromised.The procedure was successfully completed with another polaris ultra stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.

• 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: 8619800
• Report Number: 3005099803-2019-02565
• Device Sequence Number: 2039320
• Product Code: FAD
• UDI-Device Identifier: 08714729762904
• UDI-Public: 08714729762904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/25/2019

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: 08/07/2021
• Device Model Number: M006193131090
• Device Catalogue Number: 193-131-09
• Device Lot Number: 0022939917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1