MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES LLC MANOSCAN AR 3D PROBE; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number	3885
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
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 sheath balloon broke of the catheter when doctor removed it from the patient with 30cc of air still in the balloon.The physician attempted to remove the balloon from the patient without success and advised that the balloon will pass.There was no patient harm or injury.

• Brand Name: MANOSCAN AR 3D PROBE
• Common Device Name: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES LLC; 5860 uplander way; culver city CA 90230
• MDR Report Key: 8640776
• Report Number: 3005344223-2019-00008
• Device Sequence Number: 13925503
• Product Code: FFX
• UDI-Device Identifier: 04260167480954
• UDI-Public: 04260167480954
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K151086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 3885
• Device Catalogue Number: 3885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1