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

Model Number	EXPORTAP
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 was deformed in vivo.It was noted that the device was frayed upon removal from the patient.The device was inspected prior to use and prepped per ifu with no issues noted.No resistance was encountered during advancement of the device.No excessive force was used during insertion or delivery.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the deformation was noted on the catheter.No resistance was noted while removing the device from packaging.No resistance was noted during removal of the device.Excessive force was not used.The device was not excessively torqued.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.
Additional Manufacturer Narrative
Product analysis: one export ap ce aspiration catheter was returned for analysis.The extension line was attached upon return and was removed with no issues noted.Kinks were evident on the extension line.The guidewire lumen was noted to have lifted from the device.The peeled back section was observed at 7cm from the distal end of the device.The peeled back section was measured, and it was approx.25mm in length.It was possible to load a guidewire through the lumen, and the torn lumen could be visualized.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: 23538566
• Report Number: 1220452-2025-00027
• Device Sequence Number: 9961583
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: (01)00613994431745(17)270131(10)0012650549
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K081573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: 0012650549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 01/19/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/24/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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