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

Model Number M006193131090

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

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 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.

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 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
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8619800
• MDR Text Key: 145393088
• Report Number: 3005099803-2019-02565
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729762904
• UDI-Public: 08714729762904
• Combination Product (y/n): N
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1