MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL URETERAL STENT SYSTEM; STENT, URETERAL

Model Number	32905
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the patient was experiencing intense pain.A target lesion was located at kidney.Td/8/38 (bx/10) fascial dilator was selected for use.During the procedure, cons old stent was removed when exchanging of a uretic stent and replaced with new expel stent, it was pushed further into the kidney with the pusher.When the dr.Attempted to remove the pusher, it got stuck on the tip of the stent.The device was removed and pulled the whole stent system from the body.Then, the second stent was being inserted.Subsequently, the patient was experiencing great pain without sedation and the procedure went from two to four hours.No further patient complications were reported.Patient condition was stable post procedure.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Corrected brand name from fascial dilator to expel ureteral stent system.Corrected common device name from dilator, catheter to stent, ureteral.Corrected pro code from gcc to fad.Corrected model number and catalog number from 38975 to 32905.Corrected mfr site facility name from angiodynamics to boston scientific de costa rica s.R.L.Corrected mfr site country from united kingdom to costa rica.Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed no defects were noted.The stabilizer and the stent look in good condition.Dimensional inspection revealed that the stent length of 220mm was found within specification.The stabilizer length of 57.8cm was found within specification.The stabilizer was inserted in the french tool and pass without resistance in the 6fr hole.Functional inspection revealed that a mandrel of 0.038 in was inserted into the stabilizer and pass without resistance.A mandrel of 0.038 in was inserted into the stent and pass without resistance.
Event or Problem Description
It was reported that the patient was experiencing intense pain.A target lesion was located at kidney.An expel ureteral stent system was selected for use.During the procedure, cons old stent was removed when exchanging of a uretic stent and replaced with new expel stent, it was pushed further into the kidney with the pusher.When the dr.Attempted to remove the pusher, it got stuck on the tip of the stent.The device was removed and pulled the whole stent system from the body.Then, the second stent was being inserted.Subsequently, the patient was experiencing great pain without sedation and the procedure went from two to four hours.No further patient complications were reported.Patient condition was stable post procedure.

• Brand Name: EXPEL URETERAL STENT SYSTEM
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8470351
• Report Number: 2134265-2019-03238
• Device Sequence Number: 1655182
• Product Code: FAD
• UDI-Device Identifier: 08714729115663
• UDI-Public: 08714729115663
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 05/22/2019

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: 10/28/2010
• Device Model Number: 32905
• Device Catalogue Number: 32905
• Device Lot Number: 0011231753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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