MAUDE Adverse Event Report: MEDTRONIC, INC INTUITION GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	INTU180HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
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
An attempt was made to use one resolute onyx coronary drug eluting stent, one intuition guidewire, one nc euphora balloon and one launcher guide catheter during a procedure.All devices were inspected with no issues.Negative prep was performed on the resolute onyx and nc euphora devices with no issues.The intuition and launcher devices were prepped per ifu with no issues.Resistance was not encountered when advancing the launcher device, and excessive force was not used.It was reported that the resolute onyx stent dislodged during delivery to the lesion.The stent dislodged during pull and push factor of the intuition guidewire, and the guidewire broke in half, possibly due to calcification.The patient was recommended for surgery for removal of the guidewire and stent, which were removed by using the snare technique.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: the detachment occurred in the body of the guidewire.There was no complaint against the launcher guide catheter and nc euphora balloon used.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.
Additional Manufacturer Narrative
Additional information: annex d codes.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.

• Brand Name: INTUITION GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19220398
• Report Number: 1220452-2024-00026
• Device Sequence Number: 15503593
• Product Code: DQX
• UDI-Device Identifier: 00763000569952
• UDI-Public: 00763000569952
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K140695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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 Expiration Date: 06/22/2025
• Device Model Number: INTU180HS
• Device Catalogue Number: INTU180HS
• Device Lot Number: G22A05617
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 06/28/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/03/2024
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male