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

Catalog Number	NPAS-100
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Customer reported that, during the deployment of a neff percutaneous access set for a biliary drain, it was noted that the tip of the outer sheath was "frayed".The device made contact with the patient, but the customer was unable to finish placement of the device.A second device was used to finish the procedure.No patient harm was reported.
Additional Manufacturer Narrative
After further review of the record, it was determined that it should be noted that per the customer, additional information is unavailable.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the distal tip of the sheath was damaged and split.Bio matter on the device also indicated it had been used.Furthermore, the device passed all dimensional tests.There is no evidence to suggest this failure is manufacturing related and it was determined the device in this case was built to specification.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 no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number which is unrelated to the reported complaint.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.It is reasonable to suggest that the tip of the sheath was unable to withstand forces upon insertion, possibly due to a tortuous/difficult patient anatomy.However, this cannot be confirmed.We will continue to monitor for similar complaints and have notified the proper personnel about this event.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: 7426960
• Report Number: 1820334-2018-00945
• Device Sequence Number: 1630087
• Product Code: KGZ
• UDI-Device Identifier: 00827002042674
• UDI-Public: (01)00827002042674(17)201027(10)8330714
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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 Catalogue Number: NPAS-100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1