MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number M0031681900

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number was unavailable and therefore a review of the device history record could not be performed.The device is not available; therefore, a physical as well as a functional evaluation cannot be performed.However there are controls in the manufacturing process to ensure the product met specifications prior to release.Based on the information available the cause of the reported issue cannot be determined.Subject device was disposed.

Event Description

It was reported that the microcatheter radiopaque markers were misaligned.The microcatheter was exchanged and the procedure completed without clinical consequences to the patient.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5464948
• MDR Text Key: 39199705
• Report Number: 3008853977-2016-00077
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042568
• 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: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0031681900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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