MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX NEPHROURETERAL STENT; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	35375
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date month as the exact event date was not reported.
Event or Problem Description
It was reported that the stent was fractured.A 10/24 percuflex nephroureteral stent was selected for use.It was noted that the device was bent/fractured during shipping.No patient complications were reported and there was no impact on patient health as affected catheter was not used during the actual procedure.
Event or Problem Description
It was reported that the stent was fractured.A 10/24 percuflex nephroureteral stent was selected for use.It was noted that the device was bent/fractured during shipping.No patient complications were reported and there was no impact on patient health as affected catheter was not used during the actual procedure.
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date month as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.The device was returned with the metal cannula, it was observed that the percuflex nephroureteral stent does not show anomalies or damages nor evidence of use since the tip protector was in distal tip position.The metal cannula was received with several kinked section and with the proximal section broken.

• Brand Name: PERCUFLEX NEPHROURETERAL STENT
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9829708
• Report Number: 2134265-2020-03066
• Device Sequence Number: 16851549
• Product Code: FAD
• UDI-Device Identifier: 08714729031697
• UDI-Public: 08714729031697
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• 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,Followup
• Report Date (Section B): 04/15/2020

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: 04/21/2022
• Device Model Number: 35375
• Device Catalogue Number: 35375
• Device Lot Number: 0023675351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1