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

Model Number	1286
Medical Device Problem Codes	Difficult to Remove (1528); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, the catheter stuck in patient, could not be removed by physician who made the procedure and ent department finally removed the catheter using a device.It had a little rupture in white isolation right after the sensor part.Little bleeding appeared on the patient.There was a kind of tear/ laceration on the mucosa, probably from the cut in the catheter isolation that got caught on the mucosa.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that multiple photos of damage to the silicon sleeve of the catheter.This damaged area could get caught on patient anatomy during use of the catheter.It was reported that the manometry catheter was difficult to remove from patient and manometry catheter was damaged.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: nasal passage insertion, potential adverse events associated with the use of this system and catheter insertion into the nasal passage may include: discomfort, nasal pain, minor bleeding, runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation.In rare instances, the catheter may be misdirected into the trachea causing coughing or choking, the catheter may curl during intubation, and catheter position may move during the procedure.Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): GIVEN IMAGING LOS ANGELES LLC; 5860 uplander way; culver city CA 90230
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19371097
• Report Number: 3005344223-2024-00001
• Device Sequence Number: 7703755
• Product Code: FFX
• UDI-Device Identifier: 04260167482484
• UDI-Public: 04260167482484
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K151086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown