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

Model Number EXPORTAP

Device Problems Entrapment of Device (1212); Difficult to Insert (1316); Difficult to Remove (1528); Material Deformation (2976); Positioning Problem (3009); Material Split, Cut or Torn (4008)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

Image analysis: three images were provided for review.The first image provided was of the shelf carton label.The batch number and device details match the reported batch number.Two images were provided of the export device exiting the tip of a guide catheter.There also appears to be a guidewire exiting the guide catheter.There appears to be deformation to the shaft of the export catheter, with a kink evident.It is not possible to determine if the wire lumen is damaged, or if there was resistance and friction during wire movement, from the image.Product analysis: one export ap aspiration catheter was received for analysis loaded in a launcher guide catheter and a y-adaptor, which was connected to the launcher hub.A non-medtronic guide wire was loaded through the export and a vaclock syringe was connected to the export hub.The vaclock syringe was removed with no issues and no damage noted.The export device was exiting the tip of the guide catheter and deformation was noted to the proximal end of the guidewire lumen, and a kink was noted on the non-medtronic guidewire as it exited the lumen.The returned devices were placed in a water bath to disperse contrast and blood within the guide catheter and an attempt was made to remove the export, however it remained entrapped in the guide catheter.The guide catheter was then cut along its length and the luer was cut from the export device, and it was removed for further analysis.Kinks were noted on the shaft of the device approximately 6cm, 22cm and 27cm distal to the strain relief.Dried contrast was also visible along the length of the shaft.The non-medtronic guidewire was removed from the guide wire lumen with resistance noted and the od of the guidewire was confirmed as 0.014 ¿.It was observed that the deformed guidewire lumen was torn and approximately 7mm of the lumen was lifted from the shaft of the device.The od of the proximal shaft met specification.The od of the dual lumen major/minor axis met specification.The id of the guidewire lumen met specification.No other damage was evident to the remainder of 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.

Event Description

An attempt was made to use one export ap aspiration catheter during a procedure on the saphenous vein graft (svg) to the diagonal branch.The proximal and mid svg had a previously deployed non-medtronic stent with 90% in-stent restenosis (isr), a small round thrombus, and hazy opacity distal to the stent.The export aspiration catheter was being used to treat the thrombus.The device was inspected with no issues noted.The device was prepped per ifu with no issues noted.The initial attempts to cross the lesion were unsuccessful.Excessive force was not used during insertion/delivery.It was reported that the wire lumen of the aspiration catheter was damaged.The export was over the wire and there was noticeable resistance and friction from the 0.014 non-medtronic wire.There were then difficulties encountered when removing the export aspiration catheter back through the 6f launcher guide catheter.The export catheter, the wire and the launcher guide catheter were removed as one unit.There were no difficulties experienced removing the export aspiration catheter from the patient's vasculature.The patient is alive with no injury.

• 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: 18064088
• MDR Text Key: 327245932
• Report Number: 1220452-2023-00099
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: 00613994431745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXPORTAP
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0011480331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Date Device Manufactured: 10/31/2022
• 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