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

Model Number	35375
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent broke inside the patient.A percuflex nephroureteral stent was selected for use.However, during the procedure the stent broke and the end piece was somewhere inside the patient's body.A catheter was used to aid in expelling the broken stent.No patient complications were reported.
Event or Problem Description
It was reported that the stent broke inside the patient.A percuflex nephroureteral stent was selected for use.However, during the procedure the stent broke and the end piece was somewhere inside the patient's body.A catheter was used to aid in expelling the broken stent.No patient complications were reported.It was further reported that the method that was used to unlock the pigtail was the straightener.The safety tip was removed and it was loaded on a wire.However, it could not load all the way as there was a piece of plastic flap/defect noted.The device was put down and had to be removed due to ureter stenosis.A balloon inflation was performed and then reinsert the device onto the wire and noticed that the tip was missing.The missing tip could not be found on the sterile field or table nor on the floor as well as under fluoroscopy.The physician did not planned any intervention to remove the end piece, it will be passes along with the kidney stones.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Media inspection, the customer did provide one photo related to the complaint; the upn and lot number provided on the photo attached to the complaint match with the reported information in this complaint.Visual inspection, the catheter, and the metal cannula were returned for this complaint.The catheter was inspected, and no damages were observed.And the metal cannula was bent, also it was detached at distal section.Microscope inspection, under microscope it was observed that the metal cannula was detached/separated at distal section.
Event or Problem Description
It was reported that the stent broke inside the patient.A percuflex nephroureteral stent was selected for use.However, during the procedure the stent broke and the end piece was somewhere inside the patient's body.A catheter was used to aid in expelling the broken stent.No patient complications were reported.It was further reported that the method that was used to unlock the pigtail was the straightener.The safety tip was removed and it was loaded on a wire.However, it could not load all the way as there was a piece of plastic flap/defect noted.The device was put down and had to be removed due to ureter stenosis.A balloon inflation was performed and then reinsert the device onto the wire and noticed that the tip was missing.The missing tip could not be found on the sterile field or table nor on the floor as well as under fluoroscopy.The physician did not planned any intervention to remove the end piece, it will be passes along with the kidney stones.

• Brand Name: PERCUFLEX NEPHROURETERAL STENT
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16035877
• Report Number: 2124215-2022-53778
• Device Sequence Number: 5643918
• Product Code: FAD
• UDI-Device Identifier: 08714729031680
• UDI-Public: 08714729031680
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 35375
• Device Catalogue Number: 35375
• Device Lot Number: 0025795239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 01/23/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/13/2023; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown