MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422060
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject coil delivery wire was found to be kinked/bent.The main coil was not returned and was found to have been prematurely detached/separated from the delivery wire.Although functional testing was unable to be performed to replicate the reported event, it is probable that the kinked delivery wire caused the reported detachment failure during the procedure.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 event could not be replicated during analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the subject coil could not be detached.Additional information provided by the customer indicated that the device was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was moderately tortuous, no damage was noted to the proximal section of the delivery wire prior to inserting into the power supply, no damage was sustained to the delivery wire during use, the funnel of the power supply was correctly and sufficiently placed over the proximal end (proximal contact) of the delivery wire, and 3 attempts were made to detach the coil.An assignable cause of handling damage will be assigned to the as reported main coil failed/unable to detach and the as analyzed coil delivery wire kinked/bent since these issues are associated with handling of the product or portion of the product during the clinical procedure.It is possible that the subject coil was partially detached and was subsequently prematurely detached when attempting to remove the coil after the failed detachment attempt.An assignable cause of procedural factors will be assigned to the as analyzed main coil prematurely detached/separated during use since this issue is associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
Analysis of the returned device found the subject coil to have been prematurely detached/separated from the delivery wire.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• 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: 20174524
• Report Number: 3008881809-2024-00409
• Device Sequence Number: 12460612
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/09/2024

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 Catalogue Number: M0035422060
• Device Lot Number: 24813225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: White