MAUDE Adverse Event Report: MEDTRONIC, INC EXPORT AP ASPIRATION CATHETER; CATHETER, EMBOLECTOMY

Model Number	EXPORTAP
Medical Device Problem Codes	Suction Problem (2170); Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
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
It was reported that during a procedure involving one 6f export aspiration catheter, it was discovered that the guidewire lumen of the aspiration catheter was damaged.The guidewire lumen was noted to be damaged when suction was unsuccessful while inside the patient's body.The device was removed and the damage was noted to the guidewire lumen.Wire management issues occurred when the non-medtronic wire looped during use but did not occur inside the patient's body.The target lesion was located in the mid left anterior descending (lad) artery which exhibited mild tortuosity, no calcification and 95% stenosis.There was no damage noted to the packaging.The device was removed from the packaging per ifu with no issues.The device was inspected prior to use and prepped per ifu with no issues noted.Resistance was not noted during insertion of the device.Excessive force was not used during use.The guidewire was prepped as per ifu.The same model of product was replaced, and the procedure was successfully completed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: it was believed that the unsuccessful suction may be related to the damage to the export catheter.Annex d code.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: EXPORT AP ASPIRATION CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• 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: 23531528
• Report Number: 1220452-2025-00025
• Device Sequence Number: 9140867
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: (01)00613994431745(17)270131(10)0012650541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040869
• 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
• Report Date (Section B): 12/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: EXPORTAP
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0012650541
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 01/31/2025
• 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
• Patient Sex: Unknown