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

Model Number	1286
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Blood Loss (2597); Radiation Exposure, Unintended (3164)
Date of Event	08/30/2019
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, at the end of the study, it was difficult to extubate the patient.The probe got stuck and the patient was then sent to the emergency room where a chest and head x-ray was taken which showed normal, valium was given, and the probe was removed.During the recovery period, the patient experienced increased, unstoppable nasal bleeding, and had to return to the emergency room for nasal packing and an overnight stay for observation.There was a tear in the outer covering of the probe related to the removal and not to the insertion or performance during the procedure.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned sample did not meet specification as receive.The visual inspection found the silicone sleeve is damaged.The ruled tubing is discolored.The reported condition was confirmed.The investigation found the catheter calibrated, skipped thermal test due to silicone sleeve damage.The pico scope data shows all sensors are responding.The investigation found the most probable cause to be the silicone sleeve damage.The probable root cause was found to be user mishandling.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.

• 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: 9115414
• Report Number: 3005344223-2019-00011
• Device Sequence Number: 1801072
• Product Code: FFX
• UDI-Device Identifier: 04260167482484
• UDI-Public: 04260167482484
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/17/2019

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: 1286
• Device Catalogue Number: 1286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 40 YR