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	Foreign Body In Patient (2687)
Date of Event	12/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
During a ptc drain insertion on a patient with biliary stenosis following a liver transplant, the needle was inserted followed by the wire.Due to the stenosis, the wire became tangled and when the physician tried to remove it, the wire snapped.No other kit was been used at the time and the broken bit remains in the patient.The radiologists decided to leave but possible procedures are in the planning.
Additional Manufacturer Narrative
A review of the manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One mandril guide from the neff percutaneous access set from an unknown lot number was returned in a used and damaged condition.A visual examination of the wire guide was conducted.It was confirmed that the distal solder connection had separated from the inner mandril wire resulting in coil elongation.It was also confirmed that the distal solder connection was missing.The elongated coil was attached to the mandril wire at the proximal solder connection.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
During a percutaneous transhepatic cholangiography (ptc) drain insertion on a patient with biliary stenosis following a liver transplant, the needle was inserted followed by the wire.Due to the stenosis, the wire became tangled and when the physician tried to remove it, the wire snapped.No other kit was been used at the time and the broken bit remains in the patient.The radiologists decided to leave but possible procedures are in the planning.

• 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: 6206548
• Report Number: 1820334-2016-01598
• Device Sequence Number: 16372368
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)191011(10)7350298
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 06/24/2017
• 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: Other