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

Catalog Number	10302803
Medical Device Problem Codes	Break (1069); Device Issue (2379)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported (b)(6) 2016, a patient of unknown age and gender presented for a dialysis procedure.During the procedure, the physician advanced the dialysis catheter into the patient via the sheath.While advancing the catheter and attempting to tear away the peelable sheath, the sheath tore apart into several pieces.Some of the pieces remained inside of the patient.The physician had to open the patient to remove the remaining pieces of the sheath.It was reported the patient suffered no permanent harm or injury due to the event.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one 16f valved peelable sheath.A visual review of the device noted it was fractured into multiple pieces.Angiodynamics' supplier of the device was notified of the event via a scar.The device was forwarded to the vendor for analysis.The vendor performed an evaluation and discovered that the scoreline of the sheath was not present on the sample.This was a manufacturing operation that was missed during manufacturing at the supplier facility.As stated by the supplier; "as part of a previous investigation, (b)(4) modifications were made to the production line to run dpro without batching.This product was made before the corrections were implemented in november 2015".The customers reported complaint description of the sheath fracturing is confirmed.The root cause, as determined by the vendor was due to the scoring operation being missed during manufacturing.A review of the lot history records was performed for the reported packaging and component lots for the procedure kit for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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.(b)(4).

• Brand Name: DURAMAX® CHRONIC HEMODIALYSIS CATHETER SET
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5664399
• Report Number: 1319211-2016-00084
• Device Sequence Number: 16271301
• Product Code: MSD
• UDI-Device Identifier: H787103028035
• UDI-Public: H787103028035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2016

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
• Operator of Device: Physician
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 10302803
• Device Lot Number: 4989640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention