MAUDE Adverse Event Report: COOK BIOTECH UNKNOWN; NONE

Catalog Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problems Erosion (1750); Fistula (1862)

Event Type  Injury  

Event Description

On (b)(6) 2014, in a brief meeting in between surgical cases, dr (b)(6) reported a second similar event to (b)(4).Dr (b)(6) reported the patient developed an enterocutaneous fistula.Due to the lack of time at this meeting, the sales representatives requested to schedule another meeting with dr (b)(6) to discuss these two cases.Dr (b)(6) was reportedly dismissive of the idea of sharing additional details and expressed a lack of desire to follow through with a formal complaint investigation as he felt the root cause of the occurrences would be relayed back to him as a technical error.The sales representatives communicated that the feedback was valuable and important to cook and insisted on meeting again.A meeting date was set for (b)(6) 2015.Due to the illness of the sales representatives family member, the (b)(6) 2015, did not occur and was rescheduled for (b)(6) 2015.The sales representative then went on bereavement leave beginning (b)(6) 2015 and another sales representative was to follow through with meeting dr (b)(6) on (b)(6) 2015.The sales representative reported from this meeting that the biodesign was placed for repair of a parastomal hernia with presence of infection.Dr (b)(6) alleged that the biodesign eroded into the bowel and led to the development of an enterocutaneous fistula.Dr (b)(6) was not interested in providing any additional details.On (b)(6) 2015, the cook representative met with dr (b)(6); no new details were received.As of (b)(6) 2015, the cook area representative and sales manager had attempted to gather additional details from dr (b)(6) on three separate occasions.Details regarding the patient's preoperative diagnosis, patient's medical history, date of surgery, specified biodesign device, date of post-operative symptoms, any intervention performed, and patient's current status were not provided.

Manufacturer Narrative

(b)(4).The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted.Product manufacture date unknown; lot number unknown.Conclusions: root cause inconclusive.Investigation - evaluation: investigation into this feedback included a review of the limited feedback details and communication with the (b)(4) complaints unit and sales force.Summary of investigation findings: the root cause of the bowel erosion is inconclusive due to a lack of details obtained from the surgeon.Factors that could contribute to a device eroding into the bowel include but are not limited to user technique, excess tension placed on the device, the patient's underlying condition, and the viability of the bowel.Although a specific rpn was not identified, many biodesign ifus note fistula formation as a known potential complication that is possible with the use of any prosthesis.Additionally, the biodesign hernia graft ifu and the biodesign parastomal reinforcement graft ifu list bowel erosion as a potential complication.

• Brand Name: UNKNOWN
• Type of Device: NONE
• Manufacturer (Section D): COOK BIOTECH; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 4787517
• MDR Text Key: 15304997
• Report Number: 1835959-2015-00081
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• 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: 04/23/2015
• 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
• Treatment: NONE REPORTED BY THE COMPLAINANT
• Patient Outcome(s): Life Threatening