MAUDE Adverse Event Report: CORPAK MEDSYSTEMS CORFLO PEG KIT 16FR

Catalog Number 090120057

Device Problems Device Issue (2379); Material Deformation (2976)

Patient Problem Feeding Problem (1850)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for investigation, retention samples were reviewed for defects in the peg tip no defects were found.Without a sample no definitive conclusion can be made.

Event Description

During a peg placement procedure the tip would not pull through the incision in the patient's stomach wall.The loop with guide wire came through successfully but the tapered tip became lodged and would not pull through.As a result the patient had to be taken to (b)(6) and put under general anesthesia for removal.On investigation the tip had concatenated into the polyurethane of the tube and become buckled.It was their view that the pressure of extraction should not have caused this and the tube could not have been pulled through in that state.

• Brand Name: CORFLO PEG KIT 16FR
• Type of Device: PEG KIT
• Manufacturer (Section D): CORPAK MEDSYSTEMS; 1001 asbury drive; buffalo grove IL 60089
• Manufacturer (Section G): CORPAK MEDSYSTEMS; 1001 asbury drive; buffalo grove IL 60089
• Manufacturer Contact: stephanie wasielewski ; 1001 asbury drive; buffalo grove, IL 60089 ; 8474033484
• MDR Report Key: 5647000
• MDR Text Key: 45006363
• Report Number: 3009124963-2016-00011
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K882867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2016

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: 09/01/2020
• Device Catalogue Number: 090120057
• Device Lot Number: 72247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Patient Outcome(s): Other