MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035432060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for evaluation, therefore, visual analysis and functional analysis were not performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information indicated that no anomalies were noted to the device during preparation/prior to use, continuous flush was maintained throughout the procedure, and the coil detached inside the microcatheter and was removed with the microcatheter.The same microcatheter was used to complete the procedure after removing the coil.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the subject device was not returned for analysis, a cause of undeterminable was assigned to the as reported event.
Event or Problem Description
It was reported that the subject coil was prematurely detached inside the micro catheter during procedure.The physician removed the subject coil along with the micro catheter from the patient's anatomy, replaced the coil and used the same micro catheter again to complete the procedure successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9663236
• Report Number: 3008881809-2020-00028
• Device Sequence Number: 3171324
• Product Code: HCG
• UDI-Device Identifier: 04546540676016
• UDI-Public: 04546540676016
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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
• Report Date (Section B): 02/03/2020

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: 02/03/2022
• Device Model Number: M0035432060
• Device Catalogue Number: M0035432060
• Device Lot Number: 21197605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1