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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient was undergoing a percutaneous nephrostomy procedure on (b)(6) 2017 using a neff percutaneous access set.The physician placed the wire through the dilator into the renal pelvis.The wire reportedly "turned on itself and put itself in a knot." attempts were made to straighten and pull the tip.The wire sheared off while still within the renal pelvis.The sheared off portion of the wire was retrieved using a snare and biopsy clamp.No unintended sections of the device remained within the patient.There were no adverse patient consequences.The device was received for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control, specifications, dimensional verification, and visual inspection of the actual device were completed during this investigation.The device was returned in two pieces.The distal tip was returned severely elongated and separated from the proximal end.The coil diameter measured within specification but the mandril wire was severely elongated.One potential reason that the wire guide does not withstand forces during insertion, manipulation or withdrawal is excessive friction forces.Another cause is that the wire guide is withdrawn through the needle.The warning label on the wire guide holder cautions the user to not pull the distal spring coil portion of the wire guide through the needle tip.This is because pulling the coil through the needle may cause the wire guide to elongate, break or become stuck.Based on the available information it is not clear if the leading cause to this event might be associated with the medical procedure / intervention / user technique inaccuracy or an eventual malfunction of the device.While no definitive cause can be attributed to this failure, it is feasible that coils became stuck on the needle bevel during a manipulation procedure that involved some reversal of the coil through the needle tip.However, lacking evidence of this, the root cause will be listed as inconclusive.Appropriate personnel have been notified to monitor for similar complaints.Per the risk assessment no further action is required.

• 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: 6587111
• Report Number: 1820334-2017-01289
• Device Sequence Number: 369847
• Product Code: KGZ
• UDI-Device Identifier: 00827002045934
• UDI-Public: (01)00827002045934(17)200127(10)7630265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NPAS-104
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 10/08/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 10/23/2017
• 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