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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).510k status: 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
The international customer reported that, during a percutaneous transhepatic cholangiography (ptc) in which several neff percutaneous access sets were employed, the operator of the devices was reportedly having trouble with the wires that were provided in the sets.The wires appeared to become stuck in the introducer needles, and in at least one case, the wire sheared completely.The customer confirmed that no additional procedures were required as a result of the product problems, and no patient adverse events resulted from the issue.Additionally, no part of the defective devices remained in the patient.A device was kept for return, but as of the date of this report, no device has yet been received for evaluation.The customer did not report which of the four reported wires ended up shearing.Additional information regarding the complaint has been requested, but no answers have yet been provided.This report captures one of four devices which were employed in the same procedure and with the same patient.For the other three reports, please reference: manufacturer report # 1820334-2018-00648, manufacturer report # 1820334-2018-00649, manufacturer report # 1820334-2018-00650.
Additional Manufacturer Narrative
(b)(4).It was originally reported that the wire sheared.One device was returned to the manufacturer under related mfr.Report #: 1820334-2018-00648 and a preliminary visual inspection showed the device had sheared.With this information, it was determined the device reported under this mfr.Report did not shear and is therefore determined to be not reportable.

• 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: 7327665
• Report Number: 1820334-2018-00647
• Device Sequence Number: 1606097
• Product Code: KGZ
• UDI-Device Identifier: 00827002107977
• UDI-Public: (01)00827002107977(17)201014(10)8293397
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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-105-RH-NT-U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1