MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035433560
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
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.During visual inspection, the coil delivery wire was seen to be kinked.The main coil was seen to be detached.The main coil was seen to be stretched and the suture damaged.A functional evaluation was not required as the reported event was confirmed visually.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 of ¿main coil stretched¿ was confirmed based on analysis, and the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that during procedure physician noticed coil was stretched, additional information provided by the customer indicated that during the procedure, the physician experienced friction while advancing the subject coil through the microcatheter and unable to move forward.Upon pulling it back, the coil appeared stretched.Based on the review of all available information, an assignable cause of procedural factors will be assigned to reported and analyzed event of ¿main coil stretched¿, and to the analyzed events of ¿main coil prematurely detached/separated during use¿, ¿main coil suture damage¿ as these defects are 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 factors during use.An assignable cause of 'handling damage' will be assigned to the, analyzed event of ¿coil delivery wire kinked/bent¿ as the defect appears to be associated with handling of the product or portion of the product during preparation.
Event or Problem Description
The coil (subject device) was used in the medical procedure and was reported to be stretched during use.The subject device was returned for analysis and was found to be stretched, additionally it was noted to have suture damage and was prematurely detached/separated during use.Also, the delivery wire of the subject device was noted to be kinked/bent.The procedure was completed successfully, and no clinical consequences were reported to the patient.

• Brand Name: TARGET HELICAL ULTRA 3.5MM 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: 23373950
• Report Number: 3008881809-2025-00579
• Device Sequence Number: 8894424
• Product Code: HCG
• UDI-Device Identifier: 04546540711724
• UDI-Public: (01)04546540711724(17)291119(10)25282836
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: M0035433560
• Device Lot Number: 25282836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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: ECHELON 10 MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown