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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
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
International customer reported that a patient was undergoing placement of a neff percutaneous access set for a nephrostomy procedure.The physician was not able to remove the guide wire following placement of the sheath.The physician explanted the entire device and replaced it with a new set.The patient reportedly experienced a longer operating room time and additional x-ray fluoroscopic exposure.Additional event information was requested.This is one of two reports being submitted as two separate device events occurred.Reference mdr numbers 1820334-2017-01901 and 1820334-2017-01902 for both associated events.The same patient is involved in each event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, quality control, manufacturing instructions, and specifications of the device was conducted during the investigation.The complaint product was not returned.The product label was returned to confirm the rpn and lot number, in addition to 2 unopened, unused devices from the same lot (5997227).Both contained all three components.For both unused products, the introducer sheath was opened and components assembled.Both the stylet and the dilator moved easily in and out of the sheath.The wire guide had the label l_scor_rev0.The introducer sheath and dilator/stylet combo slid easily over the wire.The stylet and dilator were easily removed from the sheath with the wire in place.There did not appear to be any damage on any component.Overall wire length, coil length, proximal solder quality, end solder quality, and wire outer diameter were measured and found to be in specification.The outer diameter and inner diameter of the sheath tip and hub were also measured.There was no indication that the sheaths were manufactured out of specification.The device history record (work order) was reviewed and confirmed that no nonconformances were recorded for set lot 5997227.Since the npas-100-nt, neff percutaneous access set is supplied with component parts, the work orders for the wire (b)(4), sheath (b)(4), and needle (b)(4) were also reviewed.There were no recorded nonconformances for the wire or needle.There were non-conformances on the sheath.Lot ic5746387 had 3 nonconformances on a total of 22 parts.Thirteen of the nonconforming components were reworked or replaced, and 9 were scrapped.Two nonconformances were recorded for lot ic5827488.All nonconforming components were scrapped.A search of our complaint records determined that this is the only complaint related to lot 5997227 and all component lots.Based on the provided information and investigation of same lot product, it remains unclear what the cause of the failure mode was.The event description does not specify whether the stylet and dilator were in place inside of the sheath at the time of the event, or if the wire was only through the introducer sheath.It is possible that the metal stylet became kinked during insertion, creating resistance on the wire coil during removal.It is also possible that the wire became bent or otherwise damaged and became caught up in the introducer sheath.It is additionally possible that the wire in question is the.038" wire (not included in this set) that this product is intended to facilitate the placement of.Without further details, a definitive root cause cannot be determined.A quality engineering risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Additional Manufacturer Narrative
Correction: upon further review, it was determined this event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction as there is no indication of the malfunction leading to an ae.Further discussion with regulatory reporting, determined that needing to replace the device, longer operating room time, and additional fluoroscopy does not constitute medical/surgical intervention to preclude permanent impairment or death for this event.Therefore, this event is no longer considered a serious injury per 21 cfr part 803.3.Additionally, a review of reporting software revealed that no similar events where the wire guide in an npas set was difficult to remove have resulted in heightened patient risk.As there are no recorded incidences of serious injury due to the reported failure mode and it is not likely that serious injury would result if the event were to recur the event is not reportable per 21cfr part 803.50.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6728045
• Report Number: 1820334-2017-01902
• Device Sequence Number: 882316
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)180629(10)5997227
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2022

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-100-NT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 12/13/2017; 08/26/2022
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 12/14/2017; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female