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

Catalog Number	EXPORTAP
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
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 ap aspiration catheter was intended to be used.The lesion associated with the event was located in the proximal cx, and was severely tortuous, with 95% stenosis.No damage noted to packaging.No issues removing the device from the packaging as per ifu.The device was inspected and prepped per ifu with no issues.No resistance encountered when advancing the device.No excessive force was used during insertion/delivery.It is reported that after the device was inserted into the patient it was noted that the marker band was noted to be missing.The device was then removed and a new device used.The marker band was not found.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the physician panned to see if they could locate the marker band in the patient but it was not found.Product analysis: as received that catheter appears undamaged, the wire lumen and tip appear undamaged.The distal marker band is missing from the catheter tip and not received with the catheter.The proximal end of the wire lumen is undamaged indicating the marker was not ripped out during wire looping.The very tip of the catheter does not show damage that would indicate the marker was pushed out through the tip from proximal to distal.Closer look at the tip shows a tear in the tip material where the marker band has been ripped out of the side of the tip.There is a protrusion in the tip material from the inside out at the distal end of the tear indicating wire puncture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXPORT AP ASPIRATION CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8041712
• Report Number: 1220452-2018-00130
• Device Sequence Number: 1525823
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: 00613994431745
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120808
• 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
• Report Date (Section B): 11/21/2018

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: 08/14/2020
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0009280434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 55