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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a neff percutaneous access set was selected for an unspecified procedure.After use, an attempt was made to remove the wire guide but the wire guide had reportedly "made a loop" and separated.In another attempt to remove the wire guide, the needle was first removed and then the guide was removed with forceps.Details clarifying the event and device damage have been requested but are currently unavailable.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D10: product received on: 04apr2019.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.One damaged wire guide was returned.The coils of the guide were elongated, and the distal tip was not present.The non damaged parts of the wire were measured and found to be within specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed two related non-conformances, in which two devices were scrapped for offset coils.It should be noted there is 100% check for this failure mode and there were no related complaints reported for this lot number.Based on the information provided, the examination of the returned product, and the results of the investigation, a definitive root cause could not be determined.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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
• MDR Report Key: 8171423
• Report Number: 1820334-2018-03774
• Device Sequence Number: 16581271
• Product Code: KGZ
• UDI-Device Identifier: 00827002107977
• UDI-Public: (01)00827002107977(17)210405(10)8751405
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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 Expiration Date: 04/05/2021
• Device Model Number: N/A
• Device Catalogue Number: NPAS-105-RH-NT-U
• Device Lot Number: 8751405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1