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

Model Number	M0036181240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during a procedure, the subject coil encountered resistance while inserting inside the microcatheter.Both subject coil and the microcatheter were attempted to remove but the subject coil prematurely detached inside the patient's anatomy.The subject coil was attempted to remove but it stretched and remained inside the body.The physician has no plans to remove the subject coil from the patient's anatomy.Condition of the patient, how procedure was completed and any medical intervention done due to this event are unknown.No other information is available.
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 device was intended to be used for treatment.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.It was reported that during the procedure there was resistance inside the microcatheter, the subject coil stretched and prematurely detached, and the coil was unable to be removed from the body.Additional information provided by the customer indicated that no damage was noted to the device packaging prior to opening, 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 tortuosity of the patient's anatomy was average.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.
Event or Problem Description
It was reported that during a procedure, the subject coil encountered resistance while inserting inside the microcatheter.Both subject coil and the microcatheter were attempted to remove but the subject coil prematurely detached inside the patient's anatomy.The subject coil was attempted to remove but it stretched and remained inside the body.The physician has no plans to remove the subject coil from the patient's anatomy.Condition of the patient, how procedure was completed and any medical intervention done due to this event are unknown.No other information is available.

• Brand Name: TARGET XXL 360 12MM X 45CM
• 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: 11161993
• Report Number: 3008881809-2021-00024
• Device Sequence Number: 11638284
• Product Code: HCG
• UDI-Device Identifier: 07613327128307
• UDI-Public: 07613327128307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: M0036181240
• Device Catalogue Number: M0036181240
• Device Lot Number: 22414766
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/16/2021
• 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: MICRO CATHETER (UNKNOWN); MICRO CATHETER (UNKNOWN)
• Outcome Attributed to Adverse Event: Other