MAUDE Adverse Event Report: COOK UROLOGICAL, INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD, STENT, URETERAL

Catalog Number 039508

Device Problem Component(s), broken (1103)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

(b)(4).The remainder of the ureteral stent was then removed in its entirety so that no stent fragments were left within the pt.Of note, a more proximal area of the stent appeared to almost be broken further lending support that this stent appeared mechanically defective.(1820334-2014-00479).

Manufacturer Narrative

Event is still under investigation.

• Brand Name: SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD, STENT, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL, INC; spencer IN 47460
• Manufacturer Contact: rita harden, director ; p.o. box 227; spencer, IN 47460 ; 8123392235
• MDR Report Key: 4181084
• MDR Text Key: 5087487
• Report Number: 1820334-2014-00480
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2014

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: 09/01/2015
• Device Catalogue Number: 039508
• Device Lot Number: UF2257860
• Other Device ID Number: (01)00827002150768(17)150901(1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2014
• Distributor Facility Aware Date: 08/15/2014
• Device Age: 24 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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 Age: 5 YR
• Patient Weight: 21