MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
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.Subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure, during repositioning, the coil (subject device) slowly retreated back into the microcatheter and prematurely and mechanically detached at the junction zone.The coil was removed with the microcatheter.There were no adverse consequences to the patient.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7936352
• Report Number: 3008881809-2018-00431
• Device Sequence Number: 13876293
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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
• Report Date (Section B): 10/04/2018

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: 08/31/2020
• Device Catalogue Number: M0036181040
• Device Lot Number: 19929899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1