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	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
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 used during a procedure to treat a lesion in the ostium of the rca and cx arteries.There was no tortuosity and severe calcification.No damage was noted to packaging.The device was removed from packaging as per ifu with no issues.The device was inspected and prepped with no issues found.No resistance was encountered when advancing the device, and no excessive force was used during insertion/delivery.It is reported that during the procedure, the marking ring at the end of the suction head fell off and dropped into the blood vessels when attempting to remove the device.The detached portion remained in the body, and could not be retrieved.The detached marking ring was left in the pulmonary vein in the patient's body.No further patient injury reported.
Additional Manufacturer Narrative
Image analysis: two still images were received.One image shows the outer packaging of the device with lot details matching that of the complaint file.The second image shows a wire loaded into the wire lumen of the device.It is unclear from the image whether there is any damage to the strain relief of the wire lumen.It is unclear whether the marker band is attached to the tip of the device.One cine image was received showing the presence of the detached marker band in what appears to be the pulmonary vein of the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the surgeon made several attempts to remove the detached portion but was unsuccessful.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: 8513399
• Report Number: 1220452-2019-00048
• Device Sequence Number: 11243286
• 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,Followup
• Report Date (Section B): 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2020
• Device Catalogue Number: EXPORTAP
• Device Lot Number: 0009219397
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 08/22/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/14/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 86