MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR 150 CM 2 TIP; CATHETER, CONTINUOUS FLUSH

Catalog Number	M0031441890
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the coil was jammed inside the microcatheter.In addition, the ptfe (polytetrafluoroethylene) was visible from the distal end of the catheter.It is most probable that procedural or anatomical factors encountered during the procedure contributed to the reported event resulting in excessive force used which would have resulted in the ptfe inner lining peeling.An assignable cause of ¿cause traced to component failure¿ will be assigned to the reported and analyzed event as the issue is associated with a product that meets the design and manufacture specifications and was used in accordance with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
Analysis of the returned device found that the ptfe (polytetrafluoroethylene) coating had peeled/scraped off.There was no clinical consequence to the patient as a result of this event.

• Brand Name: EXCELSIOR 150 CM 2 TIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8406221
• Report Number: 3008881809-2019-00065
• Device Sequence Number: 312576
• Product Code: KRA
• UDI-Device Identifier: 04546540688125
• UDI-Public: 04546540688125
• Combination Product (Y/N): N
• PMA/510(K) Number: K994155
• 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
• Report Date (Section B): 03/08/2019

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: 09/30/2019
• Device Catalogue Number: M0031441890
• Device Lot Number: 19383297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR