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

Catalog Number	GEZ6200US7B
Medical Device Problem Codes	Leak/Splash (1354); Suction Problem (2170); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An export stand alone catheter was used during a procedure to treat a non-calcified, non-tortuous lesion exhibiting 100% stenosis in the mid sfa/popliteal.There was no damage noted to the packaging.The device was removed from packaging per ifu with no issues.The device was prepped per ifu with no issues.There was no resistance encountered when advancing the device and excessive force was not used.It was reported that the device failed to aspirate.There were 5 successful aspirations prior to the issue.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: there was no noticeable resistance to wire movement.There was no wire management issue during use.The procedure was successfully completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Received for analysis was one 7f export aspiration catheter.One 30ml vaclok syringe and aspiration line were also returned.No damage noted to either the syringe or aspiration line.A torsional kink was noted on the catheter located approx 23.5cm and another kink was noted 57.5cm from the strain relief.In attempt to aspirate the device, a leak was noted coming from the torsionally kinked site located approx.23.5cm from the strain relief.Closer inspection revealed a hole, resulting in water leaking out of the catheter shaft.Exposed wire braid was evident.Aspiration could not be performed.The id of the guidewire lumen was verified using a 0.015¿ mandrel.No other deformation noted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXPORT ASPIRTAION CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9102621
• Report Number: 1220452-2019-00128
• Device Sequence Number: 1912711
• Product Code: DXE
• UDI-Device Identifier: 00613994416148
• UDI-Public: 00613994416148
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2019

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 Expiration Date: 05/14/2021
• Device Catalogue Number: GEZ6200US7B
• Device Lot Number: 0009742316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/23/2019; 11/27/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/30/2019; 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR