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

Catalog Number	GEZ6200US7B
Medical Device Problem Codes	Leak/Splash (1354); Suction Problem (2170); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
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 attempt was made to use a stand alone export aspiration catheter to treat a non tortuous, non calcified soft tissue lesion exhibiting 70% stenosis in the proximal right tibial/popliteal trunk.The vessel was occluded due to thrombus.The device was inspected with no issues.The device was prepped with no issues noted.It was reported that the device was advanced towards the proximal at but it did not aspirate, it was replaced with another device and the procedure was completed successfully.The patient is alive with no injury.
Additional Manufacturer Narrative
Atherectomy was performed at the peroneal and anterior tibial with a hawk one atherectomy device.When completed, vessel occlusion/thrombus was noted.The hawkone device is not suspected to have caused or contributed to the thrombus.It was then decided to use the export device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
One export 7f catheter as received.One 30ml vaclok syringe and aspiration line were also returned.The hawkone device used during the procedure was not returned.No damage was noted to either the syringe or aspiration line.Several kinks were noted along the shaft.In attempt to aspirate the device, a leak was noted coming from two locations ¿ from kinks located approx.14cm and 43.5cm from the strain relief.Closer inspection of both kinks revealed small holes, which resulted in water leaking out of the catheter shaft, as a result aspiration could not be performed.Exposed wire braid was evident.The id of the guidewire lumen was verified using a 0.015¿ mandrel.No other deformation noted.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 ASPIRTAION CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9346209
• Report Number: 1220452-2019-00146
• Device Sequence Number: 2606802
• 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: K050139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2019

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: 08/19/2021
• Device Catalogue Number: GEZ6200US7B
• Device Lot Number: 0009881732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/20/2019; 12/04/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 11/29/2019; 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 68