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

Catalog Number	EXPORTAP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: engaged non medtronic devices included a wire, an introducer sheath, and a distal piece of a guide catheter.The catheter was cut, the extension line of the sheath was cut and the wire was kinked on the proximal end.The distal wire lumen of the export was removed from the distal section of the guide wire.The tubing was torn/detached from the export catheter.The remainder of the export catheter was not returned for analysis.The marker band was not found in the returned devices.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using an export aspiration catheter in a patient with multi vessel disease.The export was first used in the rca with no issues noted.The device was then used in a tortuous lad.No resistance was encountered.The physician reported that the device marker came off as the catheter was being advanced and positioned.The physician ended up pulling everything out as a unit with the wire and sheath, including the marker.No part of the device remained in the patient.No patient injury is reported.On review of the returned parts, the marker was not present, which was highlighted to the physician.It was confirmed under fluoroscopy that no part of the device remained in the patient.

• 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: 6983017
• Report Number: 1220452-2017-00108
• Device Sequence Number: 1228403
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: 00613994431745
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/27/2017

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: 06/16/2019
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0008683306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 118