MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ruptured aneurysm procedure, the subject coil could not be detached.The physician replaced the power supply however, the subject coil still could not be detached.Physician tried to pull the delivery wire to retrieve the subject coil and the subject coil got prematurely detached within the proximal end of the microcatheter.The physician pushed the prematurely detached subject coil into the aneurysm using the coil delivery wire.The coil delivery wire was then removed.Since, it was a small aneurysm, embolization was successfully completed with only one coil.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B1 adverse event and product problem ¿ corrected ¿ no adverse event b2 outcomes attributed to ae - corrected ¿ no ¿required intervention to prevent permanent impairment/damage (devices)¿ h1 type of reportable event - no serious injury f10 / h6 health impact code grid ¿ updated 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 device was not returned.Per the event description the subject main coil failed to detach using two different detachment devices and then detached unexpectedly during removal.It is likely that the coil partially detached using the first detachment device and then fully separated due to a physical break at the detachment zone.However, as the subject device has not been returned, this cannot be confirmed.There were no anomalies noted to the device prior to use and it was prepared per the dfu.While there are a number of potential causes for the reported issues, because a review of available information failed to identify a definitive cause and the subject device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during a ruptured aneurysm procedure, the subject coil could not be detached.The physician replaced the power supply however, the subject coil still could not be detached.Physician tried to pull the delivery wire to retrieve the subject coil and the subject coil got prematurely detached within the proximal end of the microcatheter.The physician pushed the prematurely detached subject coil into the aneurysm using the coil delivery wire.The coil delivery wire was then removed.Since, it was a small aneurysm, embolization was successfully completed with only one coil.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.0MM X 6.0CM
• 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: 19586657
• Report Number: 3008881809-2024-00275
• Device Sequence Number: 15252716
• Product Code: HCG
• UDI-Device Identifier: 07613327578652
• UDI-Public: 07613327578652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222533
• 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): 09/11/2024

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: 08/13/2026
• Device Catalogue Number: TG5413060
• Device Lot Number: 24481792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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: INZONE DETACHMENT SYSTEM (STRYKER).; MICROCATHETER (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female