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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/09/2017
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 catheter placement using a neff percutaneous access set.The wire unraveled near the tip while in the patient.The circumstances and handling surrounding the device placement are not known.The wire was forcibly removed and guidance access to the intended biliary system was lost.No sections of the device remained within the patient.The physician placed a new wire to regain access and successfully completed the procedure.No further adverse consequences were reported.The device is reportedly available for evaluation, however it has not been received to date.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, and trends was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering 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: 6395108
• Report Number: 1820334-2017-00383
• Device Sequence Number: 738117
• Product Code: KGZ
• UDI-Device Identifier: 00827002104600
• UDI-Public: (01)00827002104600(17)190908(10)7255062
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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-100-RH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 07/19/2017
• 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
• Patient Age: 63 YR