MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during a cerebral aneurysm coil embolization, the coil (subject device) did not detach.During the recovery attempts, the coil broke.The coil was recovered by means of a lasso.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.Based on the information currently available the exact cause for the reported premature coil detachment cannot be determined.
Event or Problem Description
It was reported that during a cerebral aneurysm coil embolization, the coil (subject device) did not detach.During the recovery attempts, the coil broke.The coil was recovered by means of a lasso.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7793242
• Report Number: 3008881809-2018-00355
• Device Sequence Number: 16429897
• Product Code: HCG
• UDI-Device Identifier: 04546540676481
• UDI-Public: 04546540676481
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: M0035474150
• Device Lot Number: 20370550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INZONE DELIVERY SYSTEM (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention