MAUDE Adverse Event Report: ANGIODYNAMICS DURAMAX® CHRONIC HEMODIALYSIS CATHETER SET

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported (b)(6) 2016, a patient of unknown age and gender presented for an dialysis procedure.When placing the dialysis catheter into the patient, the tip of the introducer fractured off inside of the patient.The treating physician successfully removed the tip from inside of the patient.The procedure was successfully completed using the same device.It was reported the patient suffered no permanent harm or injury due to the event.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Received one (1) 16f valved peelable sheath.A visual review of the sheath noted that the tip is damaged/fractured.The device was forwarded to angiodynamics' supplier for a device evaluation and root cause determination.Per the supplier's response, this failure is under investigation at the vendor facility ((b)(4)).A root cause could not be determined at this time as the investigation is ongoing.The customers reported complaint of the tip fracturing is confirmed.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.During the packaging process at angiodynamics, each component put into the kit is 100% visually inspected for defects.The instructions for use which is supplied to the end user with this catalog number states "dilators and catheters should be removed slowly from the sheath.Rapid removal may damage the valve members resulting in blood flow through the valve.Never advance or withdraw guide wire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: DURAMAX® CHRONIC HEMODIALYSIS CATHETER SET
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 5866398
• MDR Text Key: 51784537
• Report Number: 1319211-2016-00113
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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