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

Model Number M001221370

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

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

Same case as: 2134265-2016-09170.It was reported that the outer sheath split.Two 8/24 percuflex¿ nephroureteral stents were selected for use.During introduction, the outer sheath split while loading on the cannula.The same thing happened with the other device.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: PERCUFLEX¿ NEPHROURETERAL STENT
• 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: 6039483
• MDR Text Key: 57806717
• Report Number: 2134265-2016-09171
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860267
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2018
• Device Model Number: M001221370
• Device Catalogue Number: 22-137
• Device Lot Number: 17873195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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