MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK XT-17 STANDARD STRAIGHT; CATHETER, PERCUTANEOUS

Catalog Number	M003C1775ST0
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports.
Event or Problem Description
It was reported that the marker of the microcatheter appeared fractured under fluoroscopy the physician removed the marker with the microcatheter.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the device found that the distal and proximal marker bands were confirmed to be intact.Functional testing did not reveal any anomalies of the radiopaque markers.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event could not be confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that the marker of the microcatheter appeared fractured under fluoroscopy the physician removed the marker with the microcatheter.There were no adverse consequences to the patient.

• Brand Name: XT-17 STANDARD STRAIGHT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8438539
• Report Number: 3008881809-2019-00077
• Device Sequence Number: 19375690
• Product Code: DQY
• UDI-Device Identifier: 07613252714866
• UDI-Public: 07613252714866
• Combination Product (Y/N): N
• PMA/510(K) Number: K142565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 07/31/2019
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 19880769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1