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

Catalog Number M0031681910

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Event Description

It was reported that during procedure, while a guidewire (non-stryker) device was advance in the microcatheter (subject device), the guidewire was coming out of the microcatheter wall and not out of the tip of the microcatheter.The guidewire was not in the distal lumen anymore but next to the distal tip marker.The microcatheter was uneventfully removed from the patient and there was no consequences to the patient.It was not possible to reproduce the reported issue outside of the patient.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the device was kinked/bent at approx.5cm from the distal end.During functional testing, the device was flushed with saline and no leaks were noted along the catheter shaft.The device was flushed under pressure and no leak was noted.This was confirmed by another team member.A 0.0158¿ patency mandrel was advanced through the catheter with resistance noted while passing through the distal end of the catheter due to the kinked/bent distal catheter shaft.The catheter kink and the friction were likely due to procedural factors limiting the performance of the device during the clinical procedure.The reported catheter shaft hole/perforation was not confirmed based on the observed device analysis.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.

Event Description

It was reported that during procedure, while a guidewire (non-stryker) device was advance in the microcatheter (subject device), the guidewire was coming out of the microcatheter wall and not out of the tip of the microcatheter.The guidewire was not in the distal lumen anymore but next to the distal tip marker.The microcatheter was uneventfully removed from the patient and there was no consequences to the patient.It was not possible to reproduce the reported issue outside of the patient.

• 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
• MDR Report Key: 7438410
• MDR Text Key: 105759397
• Report Number: 3008881809-2018-00171
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K042568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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: 09/30/2020
• Device Catalogue Number: M0031681910
• Device Lot Number: 20191059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 04/23/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRAXCESS GUIDEWIRE (MICROVENTION INC.)
• Patient Age: 66 YR