MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number UNK_NEU

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

This is report 2 of 3 filed under the same literature article.The subject device is not available.

Event Description

The interventional neuroradiology journal published a retrospective analysis of patients with intracranial aneurysms that were treated with balloon remodeling using transform occlusion balloon catheters from january 2013 to february 2014.Thirty-three patients harboring 36 intracranial saccular aneurysms were treated during 33 procedures.Eleven men and 22 women with a mean age of 56 ± 13 years.The literature results documented two perioperative thromboembolic events and one technical complication during the use of the occlusion balloon catheters.In one of the two perioperative complications experienced with the occlusion balloon catheter, a patient experienced an occlusion of the inferior branch during treatment of a ruptured middle cerebral artery (mca) bifurcated aneurysm.The occlusion was promptly reopened with balloon angioplasty using the transform balloon, without distal migration of the clot or ischemic complication.In the second perioperative complication experienced with the occlusion balloon catheter, a patient experienced a reversible dysarthria post procedure.Diffusion-weighted imaging showed a small ischemic complication in the genu of the corpus callosum.A technical complication occurred in another case where a small perforation of the balloon catheter (subject device) occurred during the withdrawal of the microcatheter used for coiling.There is no clear explanation for the event, but it was noted in the article that it was likely that the balloon catheter was overinflated during preparation and testing, thus weakening the wall.No specific details associated with product part number and patient¿s status post procedure were provided.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 7123977
• MDR Text Key: 95608044
• Report Number: 3008881809-2017-00523
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1