MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the coil (subject device) had difficulty advancing inside the microcatheter, and was found to be prematurely detached inside the microcatheter during the procedure.The coil was placed in the vessel by pressing with a delivery wire, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the coil (subject device) had difficulty advancing inside the microcatheter and was found to be prematurely detached inside the microcatheter during the procedure.The coil was placed in the vessel by pressing with a delivery wire and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the coil was not advanced or retracted with force.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TARGET XXL 360 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10774505
• Report Number: 3008881809-2020-00324
• Device Sequence Number: 1126866
• Product Code: HCG
• UDI-Device Identifier: 07613327466379
• UDI-Public: 07613327466379
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 10/29/2022
• Device Model Number: M0036180520
• Device Catalogue Number: M0036180520
• Device Lot Number: 21894080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: UNKNOWN MICROCATHETER (UNKNOWN MANUFACTURER)