MAUDE Adverse Event Report: GIVEN IMAGING, INC.; BRAVO PH CAPSULE DELIVERY DEVICE

Lot Number 37381Q (X2) 37865Q (X1)

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2018

Event Type  malfunction  

Event Description

The patient was here for egd with bravo ph capsule placement.During procedure the doctor attempted to place the bravo capsule at 29 cm in the esophagus.Following the sixty second vacuum application, the doctor broke suction before deploying the device.Another sixty seconds of suction was applied then the device was deployed followed by the standard discontinuation of suction and twisting motion to free the device.When the delivery device was removed from the mouth the probe was still sitting on it loosely.With the thought process that the interruption of suction initially may have caused this, another bravo probe from the same box and lot was used.This time all suction, deployment, discontinuation of suction and twisting was performed appropriately and without difficulty by the doctor.Upon examination of the capsule with the edg scope, the capsule was found to be in the esophagus, but not secured to the mucosal wall.The device was retrieved and a third capsule; one from a brand new box with a different lot number was tried.This time the doctor performed all steps of deployment as they should have been.When he attempted to twist the deployment device off, he noticed a slight resistance.Instructions on the handle tell you how to break the handle to complete deployment if resistance is met.Again, the doctor performed these steps appropriately.When the edg scope was placed to confirm the capsules location, it was not found in the esophagus.When backing the scope out, the capsule was found resting in the oropharynx.Several attempts were made to remove it, and finally this was accomplished with a glidescope and mcgills forceps.

• Type of Device: BRAVO PH CAPSULE DELIVERY DEVICE
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7241970
• MDR Text Key: 99121337
• Report Number: 7241970
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 37381Q (X2) 37865Q (X1)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1