MAUDE Adverse Event Report: ANGIODYNAMICS, INC DURAMAX CHRONIC HEMODIALYSIS CATHETER

Catalog Number H787103028031

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2018

Event Type  malfunction  

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.Complaint # (b)(4).

Event Description

It was reported that during a dialysis procedure, the duramax catheter fractured during insertion.The catheter broke-off about an inch below the hub while the treating physician was suturing the catheter in place.The catheter was removed and set aside.He repeated the procedure with another duramax catheter without incident.There was no patient injury due to this event.The reported disposable device has been returned to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was an opened duramax catheter.A visual examination of the returned device noted the catheter was fractured into 2 pieces, with the site of the fracture located approximately 1" below the bifurcate suture wing.The catheter exhibited a pinch mark at the fracture site.The customer's reported complaint of "the catheter fractured completely during insertion" is confirmed, however a definitive root cause cannot be determined.A review of the lot 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.The instructions for use, provided to the end user with this product, states: "do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Examine catheter lumen and extensions before and after each treatment for damage.Caution: do not clamp the dual lumen portion of the catheter.Clamp only the extensions.Do not use serrated forceps, use only the in-line clamps provided." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: DURAMAX CHRONIC HEMODIALYSIS CATHETER
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8116818
• MDR Text Key: 129158703
• Report Number: 1319211-2018-00117
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787103028031
• UDI-Public: H787103028031
• Combination Product (y/n): N
• PMA/PMN Number: K101843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: H787103028031
• Device Lot Number: 5381033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1