MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number DXT5JL35

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

An attempt was made to use one 5f dxterity diagnostic catheter during a coronary angiography procedure.The device was not inspected before use.The device was prepped per ifu with no issues noted.It was reported that when pushing the non-medtronic guidewire into the dxterity catheter it was found that the dxterity catheter was incompletely broken from the opening connector.The device tip was noted to be cracked/damaged during procedure.During the operation the dxterity device and the guidewire had entered the blood vessel and under fluoroscopy it was found that the tip of the dxterity was damaged.However, the device did not cause any damage to the patient's blood vessels.The tip did not break into separate parts, the white part of the tip end was cracked.It was detailed that during the use of device, the tip end could not be connected to the other devices.There was no problem with the connector and no damage to the luer.The non-medtronic guidewire was inserted from the tip end.No device or connector was attached to the dxterity.The device was replaced with a new medtronic dxterity device with no issues.The connector was successfully connected with the replacement angiography device.The surgery was completed smoothly.No patient injury was reported.

Manufacturer Narrative

Image analysis: one image was received showing the distal section of the diagnostic catheter with a guidewire exiting the distal section.The tip did appear to be deformed in the image however it was not possible to determine accurately the type of deformation sustained to the tip.Insertion issues could not be confirmed from the image.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

Additional information: annex d code.Correction: annex b code.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: DXTERITY
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18703940
• MDR Text Key: 336403990
• Report Number: 1220452-2024-00015
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00643169689299
• UDI-Public: 00643169689299
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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
• Device Operator: Health Professional
• Device Model Number: DXT5JL35
• Device Catalogue Number: DXT5JL35
• Device Lot Number: 60449986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/23/2024
• Date Device Manufactured: 03/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male