MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available.
Event or Problem Description
It was reported that during the procedure of the embolization, the subject coil was detached while placing in the microcatheter.No clinical consequences to the patient was reported.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Review and analysis of all available information failed to indicate an assignable cause or probable assignable cause for the reported event.Based on the information available the exact cause for the reported event cannot be determined.
Event or Problem Description
It was reported that during the procedure of the embolization, the subject coil was detached while placing in the microcatheter.No clinical consequences to the patient was reported.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6090314
• Report Number: 3008881809-2016-00252
• Device Sequence Number: 1168302
• Product Code: HCG
• UDI-Device Identifier: 04546540676009
• UDI-Public: (01)04546540676009(17)181130(10)18722379
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102672
• 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): 02/09/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: M0035432040
• Device Lot Number: 18722379N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 02/09/2017
• 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: MICROCATHETER (ENCHELON)