MAUDE Adverse Event Report: COOK, INC. SOF-FLEX; CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Catalog Number G15077

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 07/16/2015

Event Type  malfunction  

Event Description

A (b)(6) baby had a stent placed for a ureteropelvic junction repair.Forty-eight days later, the infant's mother found what appeared to be pieces of the stent in her diaper.A surgeon took her into the operating room to extract the fractured stent.

• Brand Name: SOF-FLEX
• Type of Device: CATHETER, SUPRAPUBIC (AND ACCESSORIES)
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington, IN 47404
• MDR Report Key: 5035748
• MDR Text Key: 24312302
• Report Number: 5035748
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: G15077
• Device Lot Number: U2259294
• Other Device ID Number: STENT 4.7FRX10CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 1 YR