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

Catalog Number EXPORTAPCE

Device Problems Fracture (1260); Use of Device Problem (1670); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

One export ap ce aspiration catheter was attempted to be used in a procedure.It was reported that the distal tip of the export catheter had a laceration/loose component.It was stated that there was a fracture on the coating of the catheter towards the distal/working tip.A laceration was identified on the device.The device was opened and used in the procedure.The device was loaded on the guidewire.The device was also found to be expired.No patient injury reported.

Manufacturer Narrative

Please note that this device (export apce) is not marketed in the united states; however, it is similar to the united states marketed device (export ap).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.Deformation was evident to the proximal end of the guidewire lumen and approximately 5mm had lifted from the shaft.Blood was visible in the guidewire lumen.A 0.014 inch guidewire was backloaded through the distal tip and advanced proximally, however it would not pass through the deformed proximal end of the guidewire lumen.The pouch label was also returned, and it was noted that the expiry date was 23-mar-2023.The lot number on the label match the reported lot number.There was no evidence of a fracture or detachment on the device.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: EXPORT AP ASPIRATION CATHETER
• Type of Device: 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: 17823181
• MDR Text Key: 324331086
• Report Number: 1220452-2023-00092
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Catalogue Number: EXPORTAPCE
• Device Lot Number: 0011134157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Date Device Manufactured: 03/23/2022
• 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