MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported the coil (subject device) stretched and a retriever was used to remove the coil.There was no clinical consequence to the patient as a result of this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.In the case of this complaint it is possible that the main coil stretched due to some anatomical or procedural factors encountered during use due to which medical intervention was required to remove it, possibly leading to as reported event.Therefore;an assignable cause of ¿undeterminable¿ will be assigned to the " patient medical intervention required,and main coil stretched", as the device was not returned and the review and analysis of all available information failed to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported the coil (subject device) stretched and a retriever was used to remove the coil.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 3MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8118453
• Report Number: 3008881809-2018-00507
• Device Sequence Number: 18882595
• Product Code: HCG
• UDI-Device Identifier: 04546540675873
• UDI-Public: 04546540675873
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: M0035423040
• Device Lot Number: 20195488
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/21/2019
• 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: TREVO RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention