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	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.The returned device was found with the catheter shaft middle section detached/separated.The flexible cannula was not returned for analysis.The suture string was not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21jul2020.It was reported that the flexible cannula broke inside the catheter.An 8.3/24 expel nephroureteral stent system with twist-loc hub was selected for use.During the procedure, it was noted that the flexible cannula broke inside the catheter when the physician tried to implant the device.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.However, device analysis revealed that the catheter middle section was detached/separated.

• 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: 10326501
• Report Number: 2134265-2020-09934
• Device Sequence Number: 3209770
• Product Code: FAD
• UDI-Device Identifier: 08714729860938
• UDI-Public: 08714729860938
• Combination Product (Y/N): N
• Initial Reporter Country: RQ
• PMA/510(K) Number: K141344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: 09/26/2020
• Device Model Number: 32899
• Device Catalogue Number: 32899
• Device Lot Number: 0021185470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1