MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject coil was repositioned several times within the shaft of microcatheter, the coil no longer moved as intended and became stretched.Operator removed the coil with the entire microcatheter and replaced with a new device and completed the procedure successfully without clinical consequences to the patient.
Additional Manufacturer Narrative
G4 pma/510(k - corrected 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 product was not returned.It was reported that the coil was repositioned several times within the shaft, the coil no longer moved as intended and became stretched.The coil then detached inside the microcatheter.An assignable cause of undeterminable will be assigned to this complaint as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during the procedure, the subject coil was repositioned several times within the shaft of microcatheter, the coil no longer moved as intended and became stretched.Operator removed the coil with the entire microcatheter and replaced with a new device and completed the procedure successfully without clinical consequences to the patient.

• Brand Name: TARGET HELICAL ULTRA 2MM X 8CM
• 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: 21338325
• Report Number: 3008881809-2025-00072
• Device Sequence Number: 19789823
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: (01)04546540676023(17)270424(10)24898656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: M0035432080
• Device Lot Number: 24898656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown