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

Model Number 1286

Device Problem Difficult to Remove (1528)

Patient Problem Sore Throat (2396)

Event Date 08/09/2023

Event Type  Injury  

Event Description

According to the reporter, the catheter was inserted via nostril without any resistance to 52 cm.The procedure went well with routine water swallow without any complications.When the catheter was pulled out, it got stuck at 46cm and would not retrieve further.At 46cm mark, a small tear on the plastic sheath was visible.To investigate further the patient was swiftly moved to the endoscopy room and anesthetized under the anesthetic with an endotracheal tube inserted.The endoscope went into the esophagus and the tip of the manometry catheter was sitting above the cardio esophageal junction as expected.No mechanical obstruction was seen in the entire esophagus or in the oropharynx.The white part of the catheter was not visualized, and the "obstruction" was felt to be in the nasal passage.The nasal passage was examined using a flexible nasal endoscopy.The patient has a deviated septum to the right nostril and enlarged turbinate.The torn plastic sheath was felt to be caught in the narrow passage preventing the catheter from being removed.The physician gradually maneuvered the catheter under visualization and managed to retrieve it with the sheath intact.No forceps were required.There was no immediate complication and the patient recovered well post-operatively apart from nasal congestion and sore throat.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the silicon sleeve had damage at the 46 cm mark.During the analysis, sensor 2 was failed on pico-scope test.Preliminary atp testing revealed that the catheter failed to calibrate on sensors 2 ,8,14 and 20.This failure every 6 sensors implies wire harness damage.It was reported that the catheter was difficult to remove from patient.The reported issue was 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.A secondary review of the device history records found no potentially contributing factors.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
• Type of Device: 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: 17667489
• MDR Text Key: 322473495
• Report Number: 3005344223-2023-00003
• Device Sequence Number: 1
• Product Code: FFX
• UDI-Device Identifier: 04260167482484
• UDI-Public: 04260167482484
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1286
• Device Catalogue Number: 1286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 45 KG
• Patient Race: White