MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 90 150CM; CATHETER, PERCUTANEOUS

Catalog Number M0031681910

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2015

Event Type  malfunction  

Event Description

It was reported that after opening the microcatheter an attempt was made to remove the mandrel and the tip of the microcatheter separated and pulled off.There was no patient involvement.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The microcatheter was returned with a mandrel.Device analysis revealed that the distal 3.5cm of the microcatheter was broken/fractured.The fractured distal end of the microcatheter contained a mandrel in the lumen.The fractured distal end of the microcatheter was able to move freely over the mandrel.A 0.0158¿ patency mandrel was unable to advance out through the distal end of the microcatheter due to friction likely caused by the damage observed.Information available indicated that the observed issued occurred when the technician attempted to remove the shaping mandrel from the microcatheter¿s shaft.Therefore based on all of the information available an assignable cause of handling damage was assigned to this investigation.

Event Description

It was reported that after opening the microcatheter an attempt was made to remove the mandrel and the tip of the microcatheter separated and pulled off.There was no patient involvement.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 90 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: 5315938
• MDR Text Key: 34037754
• Report Number: 3008853977-2015-00515
• 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,Followup
• Report Date: 11/23/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2016
• Device Catalogue Number: M0031681910
• Device Lot Number: 17888762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• 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