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

Model Number	3885
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they removed the catheter after the procedure, the balloon was not deflated even though the software showed there was no pressure on the balloon and the balloon was detached and remained with the patient.The balloon had to be removed.There was no patient and user harm.
Additional Manufacturer Narrative
Additional info: a2, a3, a4, b1, b2 (intervention required), b5, g4, h1 (serious injury), h6 (fdp).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when they removed the catheter after the procedure, the balloon was not deflated even though the software showed there was no pressure on the balloon and the balloon was detached and remained with the patient.They thought that the patient's anatomy was the issue which caused an airlock within the syringe.The patient subsequently did have a flexible sigmoidoscopy to retrieve the deflated, detached balloon.The catheter worked correctly during the previous procedure.There was no user harm.

• Brand Name: MANOSCAN
• 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: 9567293
• Report Number: 3005344223-2020-00001
• Device Sequence Number: 16664515
• Product Code: FFX
• UDI-Device Identifier: 04260167480954
• UDI-Public: 04260167480954
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 95