MAUDE Adverse Event Report: MEDTRONIC INC. (GIVEN IMAGING INC.) BRAVO; ELECTRODE, PH, STOMACH

Lot Number 38201Q

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 01/29/2018

Event Type  malfunction  

Event Description

The planned procedure was a bravo ph capsule deployment in the patient's esophagus.The initial capsule failed to deploy and was attributed to patient coughing.A second probe deployment resulted in the capsule falling off the deployment device during removal just above the patient's vocal cords.Mcgill forceps were used to retrieve the device.The capsule placement on the esophagus was thought to be correct, but the release off the deployment probe was felt to be the likely cause of the problem.We have had at least 7 failed deployments over a 2 month period (4 in one lot), and are concerned about choking risks to patients if the capsule is dragged up towards the patient's vocal cords during the removal of the deployment device.Several instances showed that the attachment of the capsule onto the esophageal wall was likely correct, because tissue was noted to be entrapped in the capsule needle/attachment site upon removal, and a small patch of esophageal mucosa showed a defect where the capsule was attached under endoscopic examination.Re-education was completed with the physicians, and the manufacturer was notified.A subsequent case being conducted with the manufacturer rep in the room, who was there to observe, again resulted in failure of the deployment device to release the capsule while attached to the esophageal mucosa.After two attempts to release the capsule, the emergency procedure, which requires breaking of the probe deployment device handle, eventually released the capsule from the device.Upon review, several recommendations were made to improve the device design and instructions.The manufacturer ifus do not recommend endoscopic visual verification of release of the capsule from the deployment device, however, this may be critical in avoiding a partial release or separation of the capsule from the esophageal wall during deployment probe removal.Providers should be encouraged to push the probe into the stomach to release the capsule if it is not properly deployed or released to avoid a choking risk during probe removal.The shark tip design of the deployment device has a lip which can catch on the edge of the capsule and dislodge it from the esophagus, resulting in a choking risk during probe removal.A retractable design may help avoid this issue if endoscopic verification of placement and release is not used.The plunger release appears to be failing frequently and pushing the plunger up so that the probe's white line is visible, does not always release capsule.Recently several cases have resulted in the need to break the handle to disengage the capsule.Initial failure of the probe to attach to the esophageal mucosa have been successful when depression of the plunger is attempted.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC INC. (GIVEN IMAGING INC.); 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7326758
• MDR Text Key: 102013697
• Report Number: 7326758
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 38201Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2018
• 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
• Treatment: NO
• Patient Age: 29 YR
• Patient Weight: 69