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

Catalog Number	EXPORTAP
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
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
There was no damage noted to packaging of the exportap aspiration catheter.The device was removed from packaging per ifu and inspected with no issues noted.The catheter was not prepped per ifu.It was reported that the device failed to aspirate completely.The stylette was removed prior to the attempted aspiration.No resistance was encountered when advancing the device and no force was applied during delivery.The intended lesion was in the mid diagonal branch, had mild tortuosity, severe calcification and 100% stenosis.After four unsuccessful attempts to aspirate using the catheter, the catheter was replaced with another medtronic device and the procedure was completed successfully.No injury reported.
Additional Manufacturer Narrative
Product analysis: as received no noticeable defects were noted.Under close visual inspection damage to the proximal wire lumen exit port was noted.The wire lumen was stressed, indicating the use of a guide wire in the wire lumen.During aspiration testing the catheter aspirated water into an in-house syringe without issues.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: 7380589
• Report Number: 1220452-2018-00029
• Device Sequence Number: 16452105
• Product Code: DXE
• UDI-Device Identifier: 00613994431745
• UDI-Public: 00613994431745
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/15/2018

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: 09/07/2019
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0008787702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1