MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) EXPEL¿ URETERAL STENT SYSTEM; STENT, URETERAL

Model Number H7493936108260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for analysis.Lot number was not provided therefore a ship history of previous lots sent to the customer was reviewed dhr found no issues.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

It was reported that patient injury occurred.The target lesion was located in the kidney.An 8.3/26 expel¿ ureteral stent system was selected for use.During placement of the stent, the string in the proximal tip of the stent would not allow for the pigtail to coil correctly, it was then observed that a kidney perforation had occurred.The physician then attempted to use the sheath to help the coiling of the pigtail; however, it was unsuccessful.The stent was then removed and a drain was positioned to enable recovery of the perforated kidney.The procedure was then rescheduled and was completed with a different device.No further patient complications reported.

• Brand Name: EXPEL¿ URETERAL STENT SYSTEM
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7428814
• MDR Text Key: 105401819
• Report Number: 2134265-2018-03050
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: H7493936108260
• Device Catalogue Number: H7493936108260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention