MAUDE Adverse Event Report: COOK INC NEFF PERCUTANEOUS ACCESS SET; KGZ ACCESSORIES, CATHETER

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a nephrostomy insertion procedure an attempt was made to withdraw a wire through a puncture needle, but resistance was felt.The operator attempted to advance the wire through the puncture needle, but was unable to advance it.During the attempted removal of the wire tension was applied to the wire.After removal it was noticed that the wire had elongated.Fluoroscopy confirmed that no residual wire remained inside the patient.
Additional Manufacturer Narrative
Kgz accessories, catheter.Investigation results - a visual examination of the returned used and damaged pmg-18sp-60-cope-nt mandril guide confirmed that the distal solder connection has separated from the inner mandril wire, resulting in extreme coil elongation.The solder connection was confirmed to be attached to the distal tip.A review of the device history record, manufacturing instructions, quality controls, specifications was conducted to aid in the investigation of the related product complaint.The wire guide is inspected 100% for solder and weld connections between the mandril and coiled tip.Based on the evidence displayed, in addition to the information provided by the customer, it is reasonable to assume that a section of the coil caught on the introducing needle, encountering force beyond design requirements when attempting to manipulate and/or remove the mandril guide.Affixed to the wire guide's protective shipping tube is a caution label that pictorially cautions against the reverse process of withdrawing the wire guide in the needle as damage may occur.We can also advise that manipulation of the wire through the needle may cause damage to the coil.Per risk assessment, no additional risk mitigation is required at this time.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5922474
• Report Number: 1820334-2016-00855
• Device Sequence Number: 588477
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)180311(10)5712365
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2016

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: NPAS-100-NT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1