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

Catalog Number	M0036180620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure subject coil was prematurely detached while advancing in the microcatheter.The subject coil was removed with the entire microcatheter, and procedure was completed successfully with another device.There were no clinical consequences to the patient reported as a result of 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 coil was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 subject coil was not returned.Additional information provided by the customer indicated that continuous flush was not set up and maintained throughout the clinical procedure.In the case of this complaint, it is probable that lack of continuous flush contributed to the reported event.Per the dfu: in order to achieve optimal performance of the detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the detachable coil.An assignable cause of use error will be assigned to the as reported code main coil prematurely detached/separated during use, 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.
Event or Problem Description
It was reported that during the procedure subject coil was prematurely detached while advancing in the microcatheter.The subject coil was removed with the entire microcatheter, and procedure was completed successfully with another device.There were no clinical consequences to the patient reported as a result of this event.

• 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: 19462523
• Report Number: 3008881809-2024-00249
• Device Sequence Number: 12744177
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 08/09/2024
• Device Catalogue Number: M0036180620
• Device Lot Number: 23057583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2021
• 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: BISHOP MICROCATHETER (PIOLAX)
• Patient Age: 82 YR
• Patient Sex: Female