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	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during endovascular coil embolization procedure in a patient with splenic artery aneurysm, when the subject coil was about 5 cm out from the tip of the microcatheter, it was pulled back for repositioning, resulting in premature detachment.The entire microcatheter was removed, but the detached coil remained inside the aneurysm toward the guide catheter and had to be retrieved with a snare device.The coil was replaced with a new one and the procedure was completed successfully.There was no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that during endovascular coil embolization procedure in a patient with splenic artery aneurysm, when the subject coil was about 5 cm out from the tip of the microcatheter, it was pulled back for repositioning, resulting in premature detachment.The entire microcatheter was removed, but the detached coil remained inside the aneurysm toward the guide catheter and had to be retrieved with a snare device.The coil was replaced with a new one and the procedure was completed successfully.There was no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
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, visual testing as well as functional 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 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, the tortuosity of the patient's anatomy was normal, the device was used in a splenic artery aneurysm, a non-stryker microcatheter was used with the subject coil, the coil was advanced slowly and gently without applying excessive force, there was no torque given where advancing the delivery wire, there was no resistance while advancing or retracting the coil within the microcatheter, and there was no attempt made to detach the coil using an inzone.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.

• 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: 16547825
• Report Number: 3008881809-2023-00129
• Device Sequence Number: 6042599
• 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): 04/11/2023

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: 04/02/2025
• Device Model Number: M0036181240
• Device Catalogue Number: M0036181240
• Device Lot Number: 23489847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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: EN SNARE DEVICE (UNKNOWN); LANTERN MICROCATHETER (MEDICO¿S HIRATA); RUBY COIL (MEDICO¿S HIRATA)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown