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

Model Number	32899
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient became septic.On (b)(6) 2021, the 8.3/24 expel nephroureteral stent system with twist-loc hub was placed on the patient.However, the drain was obstructed and patient became septic as a result.During the exchange on (b)(6) 2021, the replacement drain would not form a pigtail at the proximal end.They had to remove it and the procedure was completed with another of same device.The physician is concerned that the original drain became obstructed so soon, especially in a nu.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The returned device was found with the shaft proximal section detached/separated.The hub section was not returned with the device.The catheter shows evidence of cut at section detached.Additionally the device shows evidence calcification at distal section.Under microscope inspection the proximal section detached shows cut evidence and the distal section is calcified.
Event or Problem Description
It was reported that patient became septic.On (b)(6) 2021, the 8.3/24 expel nephroureteral stent system with twist-loc hub was placed on the patient.However, the drain was obstructed and patient became septic as a result.During the exchange on (b)(6) 2021, the replacement drain would not form a pigtail at the proximal end.They had to remove it and the procedure was completed with another of same device.The physician is concerned that the original drain became obstructed so soon, especially in a nu.No further patient complications were reported.It was further reported that the drain was placed in the left kidney.Sediment caused the device to be obstructed that lead to sepsis.When the drain was placed and the doctor attempted to pull on the suture string to form the pigtail that would hold the drain in place inside the kidney, the drain would not form a pigtail.Patient is doing well.
Event or Problem Description
It was reported that patient became septic.On (b)(6) 2021, the 8.3/24 expel nephroureteral stent system with twist-loc hub was placed on the patient.However, the drain was obstructed and patient became septic as a result.During the exchange on (b)(6) 2021, the replacement drain would not form a pigtail at the proximal end.They had to remove it and the procedure was completed with another of same device.The physician is concerned that the original drain became obstructed so soon, especially in a nu.No further patient complications were reported.It was further reported that the drain was placed in the left kidney.Sediment caused the device to be obstructed that lead to sepsis.When the drain was placed and the doctor attempted to pull on the suture string to form the pigtail that would hold the drain in place inside the kidney, the drain would not form a pigtail.Patient is doing well.

• 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: 11654206
• Report Number: 2134265-2021-04380
• Device Sequence Number: 3610054
• Product Code: FAD
• UDI-Device Identifier: 08714729860938
• UDI-Public: 08714729860938
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2021

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: 11/12/2023
• Device Model Number: 32899
• Device Catalogue Number: 32899
• Device Lot Number: 0026353535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 07/10/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/09/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention