MAUDE Adverse Event Report: COOK INC SAFE-T-J NEPHROSTOMY DRAINAGE SET FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during insertion of the drain for pleural effusion reasons an entry needle was placed under ultrasound guidance, and the guide-wire passed through the needle and into the collection.The needle was removed and the cook pigtail drain with plastic stiffener was advanced over the guide-wire.Reportedly there were no issues until the registrar attempted to remove the guide-wire and plastic stiffener and met with resistance; when the wire was eventually removed it had snapped.There was a delay in the procedure however the case was completed with no harm to the patient reported.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
One attached complaint report from the site reported that the procedure was for pleural effusion drainage; while a second report described it as an ascites drainage procedure.Although the procedure is unclear, this does not impact the assessment of the failure mode or root cause.Investigation - evaluation: a review of the device history record, drawing, manufacturing instructions, quality control, specifications and visual inspection of the returned device was conducted during the investigation.Visual examination of the nephrostomy drainage set fixed core wire guide confirmed that the distal tip weld no longer connected to the inner safety wire, resulting in the coil losing its shape and support.There was no mandrel and/or safety wire protrusion.No part of the wire was missing or otherwise completely detached.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and results of the investigation it is plausible to suggest that the distal tip weld was damaged upon withdrawal of the wire from the drainage catheter; however, the a definitive root cause cannot conclusively be determined at this time.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.Additional information: one attached complaint report from the site reported that the procedure was for pleural effusion drainage; while a second report described it as an ascites drainage procedure.Although the procedure is unclear, this does not impact the assessment of the failure mode or root cause.Investigation - evaluation a review of the device history record, drawing, manufacturing instructions, quality control, specifications and visual inspection of the returned device was conducted during the investigation.Visual examination of the nephrostomy drainage set fixed core wire guide confirmed that the distal tip weld no longer connected to the inner safety wire, resulting in the coil losing its shape and support.There was no mandrel and/or safety wire protrusion.No part of the wire was missing or otherwise completely detached.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and results of the investigation it is plausible to suggest that the distal tip weld was damaged upon withdrawal of the wire from the drainage catheter; however, the a definitive root cause cannot conclusively be determined at this time.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

• Brand Name: SAFE-T-J NEPHROSTOMY DRAINAGE SET FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6133089
• Report Number: 1820334-2016-01367
• Device Sequence Number: 13569263
• Product Code: DXQ
• UDI-Device Identifier: 00827002018419
• UDI-Public: (01)00827002018419(17)210621(10)7013930
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TSCF-38-60-3-PNS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1