MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO PH CAPSULE DELIVERY DEVICE

Model Number FGS-0313

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Inflammation (1932); Stenosis (2263); Foreign Body In Patient (2687)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported bravo ph capsule retained for more than 14 days in small bowel of patient being treated for crohn's disease.Colonoscopy was performed showing strictures and ongoing inflammation of the bowel.Patient is not experiencing any pain or discomfort.Physician is monitoring patient with watchful waiting and plans to treat inflammation by use of steroids.Physician leaning towards capsule removal if it does not pass.

Manufacturer Narrative

(b)(4).Physician confirmed that the capsule passed with the use of steroids.Patient diagnosed with crohn's disease.No surgery was needed for the removal of the capsule.

• Brand Name: BRAVO PH CAPSULE DELIVERY DEVICE
• Type of Device: BRAVO
• Manufacturer (Section D): GIVEN IMAGING LTD.; 2 hacarmel st.; p.o. box 258; new industrial park, yoqneam 20692 ; IS 20692
• Manufacturer (Section G): COVIDIEN SALES LLC, D/B/A GIVEN IMAGING; 540 oakmead parkway; sunnyvale CA 94085
• Manufacturer Contact: sharon murphy ; 540 oakmead parkway; sunnyvale, CA 94085 ; 2034925267
• MDR Report Key: 5090201
• MDR Text Key: 26230449
• Report Number: 9710107-2015-00228
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: FGS-0313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Unknown
• Patient Sequence Number: 1