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

Model Number H7493935108240

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that removal difficulties occurred.An 8.3/24 expel¿ nephroureteral stent system was selected for a nephroureteral stent drain.During the procedure, the catheter was inserted and was unable to advance into a non bsc guidewire.When the device was attempted to be removed, it became stretched and was hard to be removed out from the patient.Everything was pulled out and they had to restart.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5899389
• MDR Text Key: 52846510
• Report Number: 2134265-2016-07758
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/26/2016

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: 06/03/2017
• Device Model Number: H7493935108240
• Device Lot Number: 18747864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• 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