MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB; STENT, URETERAL

Model Number	32899
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the stent broke off.An 8.3/28 expel nephroureteral stent system with twist-loc hub was selected for use.During procedure, the device was placed onto the wire and tried to pass through the skin.However, the tip of the stent broke off causing a loss of access and wire position.Everything was then removed, and the procedure was completed with another stent of the same size.No patient complications were reported.
Event or Problem Description
It was reported that the tip of the stent broke off.An 8.3/28 expel nephroureteral stent system with twist-loc hub was selected for use.During procedure, the device was placed onto the wire and tried to pass through the skin.However, the tip of the stent broke off causing a loss of access and wire position.Everything was then removed, and the procedure was completed with another stent of the same size.No patient complications were reported.It was further reported, that the 100% stenosed target lesion was located in the mildly tortuous and mildly calcified right kidney artery.Also, the device was just removed from the patient's body without any fragments left inside the patient.The patient's condition post procedure is satisfactory.
Event or Problem Description
It was reported that the tip of the stent broke off.An 8.3/28 expel nephroureteral stent system with twist-loc hub was selected for use.During procedure, the device was placed onto the wire and tried to pass through the skin.However, the tip of the stent broke off causing a loss of access and wire position.Everything was then removed, and the procedure was completed with another stent of the same size.No patient complications were reported.It was further reported, that the 100% stenosed target lesion was located in the mildly tortuous and mildly calcified right kidney artery.Also, the device was just removed from the patient's body without any fragments lesft inside the patient.The patient's condition post procedure is satisfactory.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The drainage catheter and flexible cannula were returned for analysis.The flexible cannula was partially loaded inside the catheter.Additionally, the flexible cannula was observed kinked at middle section and the stretched in several sections.No other issues were observed in the device and no broken sections were detected.The flexible cannula was able to by unloaded without issues and some resistance was felt.Additionally, a mandrel 0.038" was inserted through the catheter and no resistance was met during its advancing.

• Brand Name: EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9439710
• Report Number: 2134265-2019-15237
• Device Sequence Number: 3623125
• Product Code: FAD
• UDI-Device Identifier: 08714729860952
• UDI-Public: 08714729860952
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2020

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: 12/17/2021
• Device Model Number: 32899
• Device Catalogue Number: 32899
• Device Lot Number: 0023099892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 01/24/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/11/2019; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR