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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG

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COOK BIOTECH BIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG Back to Search Results
Catalog Number EFPD-0.7
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/21/2018
Event Type  Injury  
Manufacturer Narrative
A review of the ifu revealed a list of precautions for the physician to review with the patient. Risks associated with failure to counsel the patient include, but are not limited to "early release of the flange, plug migration out of the fistula, fluid accumulation, infection, abscess, and failure of the fistula to heal. " the ifu states that "if the flange is retained in the patient beyond an eight-week period, the patient should be monitored for bowel obstruction, erosion, perforation or flange migration. " migration, fistula recurrence, and delayed or failed incorporation of the device are listed amongst the potential complications noted in the ifu. Lastly, the ifu notes that "the bowel fistula opening is the higher-pressure zone of the fistula, as well as the site of ingress of enteric contents into the fistula tract. The flange of the enterocutaneous fistula plug must therefore be flush against the bowel wall to restrict ingress of intestinal contents into the fistula. " the root cause of the flange migration into the fistula tract is inconclusive. Factors that could contribute to this occurrence include, but are not limited to excess tension on the device, patient post-op care and activity, patient anatomy, size of the device in comparison to fistula size, and the integrity of the bowel opening.
 
Event Description
On (b)(6) 2018, dr. (b)(6) reopened an enterocutaneous fistula tract to retrieve the flange of a biodesign enterocutaneous fistula plug. The device was implanted approximately one to two months prior. The flange reportedly migrated into the fistula tract (between the internal bowel opening and the external skin opening). The flange was retrieved with alligator forceps. A surgeon was then going to glue the fistula tract closed.
 
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Brand NameBIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG
Type of DeviceENTEROCUTANEOUS FISTULA PLUG
Manufacturer (Section D)
COOK BIOTECH
1425 innovation place
west lafayette IN 47906
Manufacturer Contact
perry guinn
1425 innovation place
west lafayette, IN 47906
7654973355
MDR Report Key7404129
MDR Text Key104608865
Report Number1835959-2018-00005
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K082682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberEFPD-0.7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/06/2018 Patient Sequence Number: 1
Treatment
NONE WERE REPORTED.
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