MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ASCERTA FIRM; STENT, URETERAL

Model Number	M0061456450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an ascerta firm ureteral stent was used during a ureteroscopy procedure.The exact date of the procedure was not reported.According to the complainant the ascerta firm ureteral stent broke in half while opening the package.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ASCERTA FIRM
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10034859
• Report Number: 3005099803-2020-01883
• Device Sequence Number: 2986106
• Product Code: FGE
• UDI-Device Identifier: 08714729861768
• UDI-Public: 08714729861768
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

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: 07/25/2022
• Device Model Number: M0061456450
• Device Catalogue Number: 145-645
• Device Lot Number: 0024171679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/07/2020
• Patient Sequence Number: 1