MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 150CM 2 TIP; CATHETER, PERCUTANEOUS

Catalog Number M0031681890

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

The subject device is not available.

Event Description

During procedure, the microcatheter (subject device) and a guidewire were crossed through the remaining thrombus.It was reported that after crossing the target lesion, angiography revealed a subarachnoid hemorrhage (sah) due to a perforation.The sah was not serious; therefore, additional treatment was not administered.The physician stated that sah "was caused by perforation with either the microcatheter or guidewire." the patient was reported to have recovered and is in stable condition.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.Vessel perforation and hemorrhage are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu); therefore, anticipated in nature.However, because the device was not returned the exact cause for the difficulties encountered during removal of the device cannot be definitively determined.

Event Description

During procedure, the microcatheter (subject device) and a guidewire were crossed through the remaining thrombus.It was reported that after crossing the target lesion, angiography revealed a subarachnoid hemorrhage (sah) due to a perforation.The sah was not serious; therefore, additional treatment was not administered.The physician stated that sah "was caused by perforation with either the microcatheter or guidewire.¿ the patient was reported to have recovered and is in stable condition.

• Brand Name: EXCELSIOR SL-10 150CM 2 TIP
• 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6074186
• MDR Text Key: 59007705
• Report Number: 3008853977-2016-00199
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K013789
• 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: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0031681890
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• 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
• Treatment: GUIDEWIRE (0.014IN ASAHI INTECC)
• Patient Outcome(s): Other
• Patient Age: 79 YR