MAUDE Adverse Event Report: ANGIODYNAMICS, INC. DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER

Catalog Number H787103012155

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

The reported defective sheath introducer has been returned to the manufacturer along with a scar, 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.A review of the device history records was performed for the 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.(b)(4).

Event Description

As reported (b)(6) 2016, a patient of unknown age and gender presented for a catheter placement.During the procedure, while the treating physician was placing the dialysis catheter in the patient's groin, the handles of the valved sheath introducer broke off.As a result of the fracture, 2 pieces of the sheath were left in patient's vein in the groin.The fractured pieces were removed, and the procedure was successfully completed.There was no report of permanent harm or injury to the patient due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was one 16f valved peelable sheath.A visual review of the returned device noted that the hub was detached and in two pieces and the sheath was peeled.The device was forwarded to angiodynamics' vendor for analysis.The vendor performed an evaluation and discovered that the tube was not properly positioned during molding.The customers reported complaint description of the sheath fracturing is confirmed.It was noted the patient suffered no permanent harm or injury and is in stable condition.A review of the lot 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 the root cause, as stated by the vendor was "due to the tube not being properly positioned during molding, potentially related to an associate error in the positioning tube or core pins too smooth causing tube blow off during molding cycle." 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: DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 5811754
• MDR Text Key: 50080140
• Report Number: 1319211-2016-00101
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787103012155
• UDI-Public: H787103012155
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

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
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: H787103012155
• Device Lot Number: 5004302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2016
• 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