MAUDE Adverse Event Report: ANGIODYNAMICS DRAINAGE CATHETER

Catalog Number 14000803

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2013

Event Type  Injury  

Event Description

As reported on (b)(6) 2014, per user medwatch (b)(4), a pt of unk age and gender presented for a drainage catheter placement.The catheter was successfully placed in the chest.There were no reports of complications or device malfunction during the procedure.Post procedure, when transferring the pt from the cart to the bed, the drainage catheter became dislodged causing the catheter to fracture.The catheter had been sewn and taped to the pt prior to dislodgement.The pt was returned to interventional radiology for removal and replacement of the drainage catheter.There was no report of harm or injury to the pt due to the event.The reported disposable device is not available for return to the mfr for eval as it has been retained by the user.

Manufacturer Narrative

It was reported that the disposable device has been retained by the user and is not available to be returned to the mfr for eval.An investigation into the root cause of this incident is currently in progress.The results of the device eval will be sent via a f/u medwatch.A review of the device history records was performed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specs.As reported, the pt suffered no permanent harm or injury due to the event.Angiodynamics is attempting to obtain add'l info in regards to the event and the pt's well-being.(b)(4).

• Brand Name: DRAINAGE CATHETER
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 3609072
• MDR Text Key: 4066333
• Report Number: 1319211-2014-00008
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002101
• 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: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14000803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• 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