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

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.

• Brand Name: BIODESIGN SURGISIS ENTEROCUTANEOUS FISTULA PLUG
• Type of Device: ENTEROCUTANEOUS 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 Key: 7404129
• MDR Text Key: 104608865
• Report Number: 1835959-2018-00005
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EFPD-0.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE WERE REPORTED.
• Patient Outcome(s): Required Intervention