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

Model Number H7493935108280

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned damaged at the proximal end.Visual inspection revealed that the hub section was detached from the rest of the catheter and suture was found broken.The detached section was not returned for inspection.Dimensional inspection of the length of the returned catheter was within specification.No other anomalies or damages were encountered.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017.It was reported that the short drain size and a damaged cannula were observed.An expel nephroureteral stent system with twist-loc hub was selected for use.During introduction outside patient's body, it was noted that the drain was too short in size and the cannula for entry became damaged.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the suture was broken.

• Brand Name: EXPEL¿ NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC¿ HUB
• 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: 6605854
• MDR Text Key: 76518937
• Report Number: 2134265-2017-05804
• 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: 05/25/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2017
• Device Model Number: H7493935108280
• Device Lot Number: 18736702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• 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