MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the physician repositioned the subject coil several times but it kept coming out of the vessel and when no resistance was felt, it was found that the subject coil had prematurely detached from the delivery wire.A snare device was used to retrieve the coil.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
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, 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 subject coil was selected to fill the vessel.It was repositioning several times for placing since the subject coil kept coming out to the parent vessel.When there was no resistance at all, it was found that the coil was prematurely detached from the coil junction part.It was also reported that 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, however it was reported that continuous flush was not set up and maintained during the procedure.As per the dfu in order to achieve optimal performance of the detachable coil system it is critical that a continuous infusion of appropriate flush solution be maintained and as this was not carried out, its likely this caused the reported premature detachment.Therefore, a probable cause of user error will be assigned to the reported event of the coil prematurely detaching since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• 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: 16060892
• Report Number: 3008881809-2022-00656
• Device Sequence Number: 6686515
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• 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
• Report Date (Section B): 12/28/2022

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: 04/26/2025
• Device Model Number: M0036121040
• Device Catalogue Number: M0036121040
• Device Lot Number: 23613499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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: SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose