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

Catalog Number	M0036121040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device history record (dhr) could not be reviewed because the batch remained unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device directions for use (dfu).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.The product was not returned, however, additional information received states that the device encountered difficulties while inserting into microcatheter due to intermittent flush maintained during the procedure, as per dfu maintaining continuous flush throughout the procedure is a critical requirement as lack of it can lead to friction or other related difficulties.Therefore, an assignable cause of user error has been assigned to this event.
Event or Problem Description
It was reported that when the coil (subject device) was inserted into the microcatheter there was resistance and the coil detached inside the catheter.The device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 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: 9451440
• Report Number: 3008881809-2019-00386
• Device Sequence Number: 19484559
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• Combination Product (Y/N): N
• 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): 12/11/2019

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: 10/07/2021
• Device Catalogue Number: M0036121040
• Device Lot Number: 20929211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1