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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the pulmonary arteriovenous malformation embolization, the subject coil was used as the 11th coil.Physician felt resistance while advancing the subject coil from the introducer sheath and also at the tip of the microcatheter.He decided to retrieve the system, while doing so the subject coil detached prematurely at the proximal end of the microcatheter.The subject coil was taken out with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the pulmonary arteriovenous malformation embolization, the subject coil was used as the 11th coil.Physician felt resistance while advancing the subject coil from the introducer sheath and also at the tip of the microcatheter.He decided to retrieve the system, while doing so the subject coil detached prematurely at the proximal end of the microcatheter.The subject coil was taken out with the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration 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 indicated that continuous flush set up and maintained throughout the procedure.No damage was noted to the 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.Friction was noted while the coil was advancing the introducer sheath.When an attempt was made to retrieve the catheter due to resistance at the tip of the microcatheter, the coil prematurely detached at the proximal end of the microcatheter.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 was assigned to this complaint of coil in catheter friction, main coil prematurely detached/separated during use and coil introducer sheath friction.

• 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
• 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: 15156880
• Report Number: 3008881809-2022-00380
• Device Sequence Number: 5268625
• 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): 01/25/2023

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: 05/18/2024
• Device Model Number: M0036181240
• Device Catalogue Number: M0036181240
• Device Lot Number: 22869646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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: LEONIS MOVA HF MICROCATHETER (SUMITOMO BAKELITE)
• Patient Sex: Unknown