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

Catalog Number M0031441890

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

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 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8406221
• MDR Text Key: 138360418
• Report Number: 3008881809-2019-00065
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 04546540688125
• UDI-Public: 04546540688125
• Combination Product (y/n): N
• PMA/PMN Number: K994155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR