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

Model Number FGS-0313

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, the delivery system was placed as usual.However, when the customer connected the vacuum hose, the delivery system's handle fell apart into two pieces.There was no extraordinary forced used to connect the vacuum hose.The customer decided not to remove the delivery device and placed the handle together again and detached the capsule completely from the delivery system.The delivery system was successfully removed with all the broken pieces.The customer used a sling to retrieve the capsule endoscopically.However, when the capsule was being pulled, it turned horizontally in the esophagus and the small metal pin at the end of the capsule perforated the esophageal wall.Clips were used to resolve the issue.The patient was prepped for the procedure and the patient was under anesthesia.There was no user harm.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel.One bravo capsule and one bravo delivery device were received for evaluation.Photos from endoscope during procedure were attached to this event.The investigation process was documented.The returned sample met specification as received by medtronic.The investigation was performed in the bio-hazard lab by qa investigator, bravo line qe, cs product specialist - the visual inspection found that the capsule needle was pushed into the capsule, but according to photos attached it is visible the needle was outside of capsule during attachment steps.The needle might have been pushed in the capsule during transport.The plunger was found to be broken in a way that determines the device was broken by user causing the capsule to be released from plunger without the internal shaft- handle pushing the push-wire so it can push the needle into the capsule as required for attachment to patients esoph.As well, the internal ribs of the handle were broken in a way that proves user mishandling.The conclusion of the analysis is: an emergency procedure was done before an attempt to attach the capsule was done causing the capsule to disconnect from delivery device with the needle extracting from capsule.The investigation team performed a reproduction attempts on other devices and was able to reproduced the issue by braking the device for emergency procedure before pushing the plunger.The reported condition was confirmed with the photos the customer provided.The investigation found the issue to be user mishandling of attachment step.The investigation identified the cause of the reported event to be user mishandling.The user has broken the handle in an emergency procedure without attaching the capsule to esoph.Contradicting the instruction for use (ifu).The ifu states: press down on the plunger with a swift and smooth motion to actuate the delivery device mechanism.Pressing down on the plunger too slowly may result in the capsule not properly attaching to the patient¿s esophagus or not detaching from the delivery device.Do not rotate the plunger while depressing it! (page 23 doc 2033 bravo guide new recorder).A review of the device history records indicated that this serial/lot number was released meeting all specifications as manufactured.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9439198
• MDR Text Key: 170076176
• Report Number: 9710107-2019-00603
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 07290101361688
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 43099Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR