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

Model Number H7493935108220

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The complaint's unit was received separated in three sections; however, the sections broken were inspected under magnification, and there are not evidence of fragmentation or disintegration.Moreover, the flexible cannula was received damaged (severely kinked).Additionally, residues were noted on the flexible cannula.Dimensional inspection was done and revealed that the catheter working length is within specification.A mandrel 0.038 inches was inserted through the catheter sections, and it passed properly without resistance.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017.It was reported that the wire was stuck in the catheter.A 8.3/22 expel ureteral stent system was selected for use.During procedure, the wire got stuck in expel catheter.No patient complications reported.However, device analysis revealed that the catheter was separated in three sections.It was further reported that the plastic obturator was inserted into the nephro-ureteral stent over a guide wire and the whole system was placed inside the patient without any problem.Difficulty withdrawing the plastic obturator from the stent was encountered.It was then noted that the shaft became elongated and broke.The whole system was withdrawn and replaced with another stent.The luer was not separated from the shaft.It was possible to withdraw the plastic obturator after it had elongated, in which case the stent was left in place.The plastic obturator was not kinked while inserting.

• 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: 7139317
• MDR Text Key: 95615753
• Report Number: 2134265-2017-12427
• 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: 12/01/2017

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 Model Number: H7493935108220
• Device Catalogue Number: H7493935108220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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