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

Catalog Number	EXPORTAP
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
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 device was intended to be used during a procedure.No damage was noted to the export aspiration catheter packaging.The device was removed from packaging per ifu with no issues noted.The device was inspected and prepped per ifu with no issues noted.The device was used in the distal rca which had moderate tortuosity, mild calcification and 100% stenosis.Resistance was encountered when advancing the device, excessive force was not applied.The catheter completely failed to aspirate the thrombus.The patient is reported as alive with no injury.
Additional Manufacturer Narrative
Slight friction was noticed with the device and the guide wire.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: 7581623
• Report Number: 1220452-2018-00070
• Device Sequence Number: 1758962
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: 00613994431745
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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: 08/23/2019
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0008768014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR