MAUDE Adverse Event Report: GIVEN IMAGING LTD. BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0635

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Inflammation (1932)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

Incident description: we were attempting to deploy a bravo in the esophagus, the first attempt was unsuccessful: the magnet did not deploy until the probe was removed from the patient, the second attempt: the bravo deployed, but did not attach to the esophagus, it was in the stomach when checked by md.Review: per 0816 am: two endo nursing intra-op minor: primary surgeon description: egd-esophagogastroduodenoscopy with biopsy single or multiple procedure completed: egd-esophagogastroduodenoscopy with biopsy single or multiple.Post-op diagnosis barrett's esophagus.Bravo placement, bravo not deployed.Per endo procedure note by doctor: attempts were made using two bravo ph probes and the probe dislodged both times.One probe was removed and the other one was noted to not have held onto the esophageal mucosa and was loose, so it was pushed into the stomach.The site of attachment where the probe was launched was noted, but it did not hold onto the mucosa.Recommendation: discharge patient to home (ambulatory).Use a proton pump inhibitor po (by mouth) daily.Return to my office in 4 weeks.We are asking the company to evaluate their probes to further evaluate the deployment system.We will need to repeat his exam once the system has been reviewed.Do not use (b)(6), or any other nonsteroidal medications for 7 days.From the procedural note: findings: the z-line was regular and was found 44 cm from the incisors.La grade a (one or more mucosal breaks less than 5 mm, not extending between tops of 2 mucosal folds) esophagitis with no bleeding was found 40 to 43 cm from the incisors.Biopsies were taken with a cold forceps for histology.Estimated blood loss was minimal.The bravo capsule was activated and then calibrated by submersion into the appropriate buffer solutions.The bravo capsule with delivery system was introduced through the mouth and advanced into the esophagus, such that the bravo ph capsule was positioned 38 cm from the incisors, which was 6 cm proximal to the ge (gastroesophageal) junction.The bravo ph capsule was then deployed and attached to the esophageal mucosa.The delivery system was then withdrawn.Endoscopy was utilized for probe placement and diagnostic evaluation.Estimated blood loss was minimal.Attempts were made using 2 bravo ph probes and the probe dislodged both times.One probe was removed and the other one was noted to not have held onto the esophageal mucosa and was loose, so it was pushed into the stomach.The site of attachment where the probe was launched was noted but it did not hold onto the mucosa.The cardia was normal.Localized mild inflammation characterized by erosions and erythema was found in the gastric antrum.The examined duodenum was normal.There were no complications.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11526909
• MDR Text Key: 240999445
• Report Number: 11526909
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 51761F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 110