MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES LLC MANOSCAN; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C

Model Number	MSS-4581-3D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the balloon did not deflate and they had to puncture it to be removed.They put 300 ml into the balloon then the customer got 60 ml out via syringe and they could not remove any more; it would not pull the air back.The customer moved the y-connector around and tried to put 20 ml back but it would not go in.They tried to remove it again and only 30 ml came back.The customer disconnected all lines and tried to bypass the y-connector but it did not work.The physician popped the balloon but it did not come out with the rest of the catheter cover during the removal of the catheter.A part of the balloon sheath was left in-situ to be removed via natural body motions.The catheter worked correctly during previous procedure.

• Brand Name: MANOSCAN
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES LLC; 5860 uplander way; culver city CA 90230
• MDR Report Key: 12519071
• Report Number: 3005344223-2021-00001
• Device Sequence Number: 16419084
• Product Code: NEZ
• UDI-Device Identifier: 04260167483719
• UDI-Public: 04260167483719
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MSS-4581-3D
• Device Catalogue Number: MSS-4581-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1