MAUDE Adverse Event Report: COOK INC LIVER ACCESS AND BIOPSY SET; FCG KIT, NEEDLE, BIOPSY

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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
International customer reported that a patient was undergoing a transjugular liver biopsy using a liver access and biopsy set.The hub broke and disconnected from the black catheter.The forces applied to the device and conditions surrounding the event are not known.A new catheter set was obtained and replacement catheter was used.There are no reported adverse patient consequences.No unintended section of the device remained within the patient.The product is reportedly available for evaluation; no device was received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, and specifications was conducted during the investigation.The visual inspection of the returned device confirmed that the hub was separated.A tear was observed measuring 3.5 cm from the distal tip of the device.No other damage was noted on the hub or catheter shaft.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 were no other reported complaints for this lot number.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.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: LIVER ACCESS AND BIOPSY SET
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6501395
• Report Number: 1820334-2017-00630
• Device Sequence Number: 13753465
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)191115(10)7446527
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1