MAUDE Adverse Event Report: COLOPLAST A/S JJ SIL CH08/12 STENOSTENT 28CM; SILICONE URETHRAL STENT

Model Number AJ4W851002

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence, should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the complaint received, during the insertion of the stent, there is a resistance at the meat of the ureter.The stent was too big and the surgeon decided to change it for a smaller stent.During the removal, the stent has broken first time at the proximal tip (outside of the patient).When the surgeon has tried to withdraw the remainder part of the stent, the stent has broken again.The distal tip was reminded in the bladder.The procedure has been prolonged about 45 minutes more, in order to withdraw the remainder part with foreign body forceps (invasive procedure) no bleeding.All remainder pieces have been withdrawn.

• Brand Name: JJ SIL CH08/12 STENOSTENT 28CM
• Type of Device: SILICONE URETHRAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-caneda, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5358083
• MDR Text Key: 35971321
• Report Number: 9610711-2016-00001
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K013921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 01/11/2016

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: Physician
• Device Expiration Date: 01/03/2016
• Device Model Number: AJ4W851002
• Device Catalogue Number: AJ4W851002
• Device Lot Number: 4226321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/11/2016
• 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
• Patient Age: 22 YR