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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/06/2017
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
The customer reported that the catheter contained in the liver access and biopsy set set broke off inside the patient during the procedure.A component broke off into the patient, but it was reportedly retrieved with no harm to the patient thereafter.Further information was not provided by the customer.The circumstance surrounding the usage and handling of the device leading up to the break were not reported.The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, instructions for use(ifu), device history record, specifications, documentation, drawings, quality control, manufacturing instructions and a visual inspection of the returned device were conducted during the investigation.One used device was returned.Upon visual examination, the distal end of the catheter had separated from the shaft distal to the tip bond.The bond was fully intact and the separated tip piece was not returned for evaluation.The surface of the catheter was apparently free of damage and excess bumps/roughness up until the point of separation.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.The ifu warns that extreme care must be exercised during manipulation and withdrawal of the catheter to prevent the catheter pulling apart.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.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6962976
• Report Number: 1820334-2017-03592
• Device Sequence Number: 718524
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)200809(10)8129498
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 01/23/2018
• 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