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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the ¿fragility of the micro-guide, probably cracked during its placement and it has a frayed aspect.¿ the reporter indicated it was impossible to remove the device completely and a distal fragment was left in intrahepatic despite progressive manipulation.The complaint form submitted indicated in the patient outcome section a fragment was not left in the patient.Another device was used.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used device was returned in damaged condition.The coiled portion of the distal wire is unraveled from the distal tip to the solder joint.Upon inspection, it is not readily apparent whether the entire coil remains intact or a portion of the distal tip may be missing.The length of the core wire was measured and found to be less than specified, confirming that an approximately 1-3 cm section of wire likely remained in the patient.The wire diameter and mandril to core wire solder joint were found to be in specification.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.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.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
An international customer reported that the micro-guide probably cracked during placement and it has a frayed aspect.The reporter indicated it was impossible to remove the device completely and a distal fragment was left in the intrahepatic area despite progressive manipulation.

• 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: 6184861
• Report Number: 1820334-2016-01519
• Device Sequence Number: 19083677
• Product Code: KGZ
• UDI-Device Identifier: 00827002104600
• UDI-Public: (01)00827002104600(17)190607(10)7027640
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 06/29/2017
• 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