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U.S. Department of Health and Human Services

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

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COOK INC LIVER ACCESS AND BIOPSY SET FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number N/A
Device Problems Material Separation (1562); Stretched (1601); Material Split, Cut or Torn (4008)
Patient Problem No Code Available (3191)
Event Date 09/12/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: glide wire, amplatz wire, 9 fr sheath to support 7 fr labs sheath (blue). Pma/510(k) #: preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported a liver access and biopsy set was used for a transjugular liver biopsy procedure. The straight catheter was used to assist access. During access, the physician found difficulty inserting the straight catheter into the cannula. The hub of the straight catheter also separated (fell off) from the catheter during this time. While removing the straight catheter due to this event, the tip of the catheter elongated and tore without completely separating. The entire assembly was successfully removed. The procedure was stopped and rescheduled for the next week during which it was completed successfully. The customer was asked why the procedure was rescheduled and responded, they only had one biopsy set, the patient became uncomfortable as they were not under general anesthesia (long procedure), and the fluro exposure time had been met.
 
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Brand NameLIVER ACCESS AND BIOPSY SET
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7953562
MDR Text Key123352860
Report Number1820334-2018-03061
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2019
Device Model NumberN/A
Device Catalogue NumberLABS-100-J
Device Lot Number7016070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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