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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Sepsis (2067); Bowel Perforation (2668); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

A biodesign enterocutaneous fistula plug (efp) was placed in a female patient for repair of an enterocutaneous fistula.The external fistula opening closed as well as the fistula tract.However, at an unspecified time post efp placement, the patient complained of pain at/near the efp placement.The internal flange of the efp had pulled through the bowel wall.This resulted in the patient having a bowel perforation and infection.The flange migrated outside of the bowel required explantation due to fear of foreign body reaction.The patient had a hospital stay post internal flange explantation.The patient was described as currently doing well.

Manufacturer Narrative

Date of event not reported by complainant.Lot number not reported by complainant.Specific rpn not reported; generic rpn efpd-[ ].Expiration date unknown as lot number not reported by complainant.Implant date not reported by complainant.Explant date not reported by complainant.Manufacture date unknown as lot number not reported by complainant.Investigation included 1) a review of the feedback details, 2) communication with the associated interventional radiologist and colorectal surgeon and 3) a review of the biodesign enterocutaneous fistula plug ifu fp0069-01j.Per the ifu, flange migration is a known potential complication.The root cause of the device flange pulling through the bowel wall and into the fistula tract is a known potential complication and was most likely due to the weakened condition of the patient's bowel wall.However, other factors to consider include, but are not limited to, excess tension placed on device at time of device placement and patient post-op activity.

• 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 (Section G): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: tony foldenauer ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 15139157
• MDR Text Key: 296977842
• Report Number: 1835959-2022-00004
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female