MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular procedure in a patient, there was resistance when the subject coil was advanced through the introducer sheath and the subject coil got stuck and detached prematurely during delivery inside the microcatheter in the patient's anatomy.The detached subject coil was removed from the patient vasculature together with the entire microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be 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.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.Additional information provided by the customer was an attempt was made to deliver the subject coil using an excelsior 1018 catheter; however, the coil got stuck and detached prematurely during delivery.It was also reported the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that continuous flush was set up and maintained during the procedure.The patients anatomy was reported to be normal.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.H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular procedure in a patient, there was resistance when the subject coil was advanced through the introducer sheath and the subject coil got stuck and detached prematurely during delivery inside the microcatheter in the patient's anatomy.The detached subject coil was removed from the patient vasculature together with the entire microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XXL 360 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14349334
• Report Number: 3008881809-2022-00215
• Device Sequence Number: 4856953
• Product Code: HCG
• UDI-Device Identifier: 07613327466386
• UDI-Public: 07613327466386
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 08/06/2022
• Device Model Number: M0036180620
• Device Catalogue Number: M0036180620
• Device Lot Number: 21646992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR 1018 CATHETER (STRYKER)
• Patient Sex: Unknown