MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 1 TIP; CATHETER, PERCUTANEOUS

Catalog Number	M0031681810
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during a procedure, when a surgeon was removing a mandrel from the subject device microcatheter, the resistance was felt and noticed that the coating was peeling.Another new device was used to complete the procedure.There were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that during a procedure, when a surgeon was removing a mandrel from the subject device microcatheter, the resistance was felt and noticed that the coating was peeling.Another new device was used to complete the procedure.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned, therefore physical and functional tests could not be performed.Based on the information currently available an assignable cause for this event cannot be determined.

• Brand Name: EXCELSIOR SL-10 150CM 1 TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8724071
• Report Number: 3008881809-2019-00178
• Device Sequence Number: 14083931
• Product Code: DQY
• UDI-Device Identifier: 04546540688200
• UDI-Public: 04546540688200
• Combination Product (Y/N): N
• PMA/510(K) Number: K013789
• 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): 07/12/2019

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: 10/24/2020
• Device Catalogue Number: M0031681810
• Device Lot Number: 21003809
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1