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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
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
It was reported by the international customer that, during a transjugular liver biopsy procedure, the 5 french catheter could not be removed from the sheath; resistance was encountered.The catheter dislodged fro the plastic hub, and the catheter was "shaved off" at the distal end.The account further clarified that no patient adverse events occurred, and no additional procedures were required as a result of the reported issue.The circumstances surrounding the handling and usage of the device are not known.The product was returned for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Corrected information: report source: foreign, health professional, user facility, company representative.Additional information: device evaluated by mfr.Investigation summary: the black catheter was returned with the hub separated and a piece of the catheter shaft torn off.The tear was approximately 16mm in length.The inner and outer diameters of the black catheter measured within specification.The inner diameter of the guiding cannula could not be measured because the distal end was deformed and non-concentric 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 failure mode.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 results of our investigation; the examination of the returned product, the hub separated and the catheter tore, the root cause was determined to be related to the user¿s technique while withdrawing the catheter from the guiding cannula.The risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.The appropriate personnel will be notified and we will continue to monitor 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: 6879511
• Report Number: 1820334-2017-02941
• Device Sequence Number: 1324961
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)200125(10)7624345
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• 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): 12/20/2017

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
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR