MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for analysis; therefore, physical as well as functional testing could not be performed.The reported issue is covered in the device directions for use.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.Information available indicated that the device was confirmed to be in good condition prior to use.The product was not returned, however, additional information received reported that the user indicated that the device was used with an incompatible microcatheter.As per the target dfu: ¿target detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters (min.Internal diameter 0.41 mm [0.016 in], max.Internal diameter 0.48 mm [0.019 in]).The medical device used to deliver the coil was not in the dfu specifications.Therefore, an assignable cause of user error has been assigned to this event.
Event or Problem Description
It was reported that during the procedure the subject coil prematurely detached within the (non-stryker) catheter inside the patient.The coil was replaced and the procedure was completed successfully.The patients medical condition was good.There were no clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9420615
• Report Number: 3008881809-2019-00376
• Device Sequence Number: 1724780
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: 04546540711533
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 12/05/2019

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: 06/30/2020
• Device Catalogue Number: M0036121240
• Device Lot Number: 19909361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1