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

Model Number 32899

Device Problem Obstruction of Flow (2423)

Patient Problem Sepsis (2067)

Event Date 03/23/2021

Event Type  Injury  

Event 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.

Event 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.

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 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
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11654206
• MDR Text Key: 245076147
• Report Number: 2134265-2021-04380
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729860938
• UDI-Public: 08714729860938
• Combination Product (y/n): N
• PMA/PMN Number: K141344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 04/20/2021; 07/10/2021
• Supplement Dates FDA Received: 05/09/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention