MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035433060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
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 the visual inspection, the distal end of the main coil was noted to be stretched and the main coil and suture were broken.Functional inspection was not required as the defect was visually confirmed.  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 was confirmed; 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 shape of the filled coil was not good enough so the operator withdrew it and tried to adjust.However when withdrawing the coil, the tip of the coil stretched.Additional information states that the device was prepared for use as per the directions for use, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush set up and maintained throughout the clinical procedure and the patients anatomy was not tortuous.The device was returned for analysis and it was confirmed that the coil had stretched, the coil was also noted to be broken/fractured with suture damage.It is probable that the main coil was stretched and subsequently broken during the attempt to remove the coil from the aneurysm.An assignable cause of procedural factors will be assigned to the reported and analyzed 'main coil stretched', and to the analyzed 'main coil broken/fractured during use' and 'main coil suture damage', as this complaint appears to be 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.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that main coil fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: TARGET HELICAL ULTRA 3MM 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: 16404353
• Report Number: 3008881809-2023-00074
• Device Sequence Number: 17020314
• Product Code: HCG
• UDI-Device Identifier: 04546540676078
• UDI-Public: 04546540676078
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/20/2023

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: 10/25/2024
• Device Model Number: M0035433060
• Device Catalogue Number: M0035433060
• Device Lot Number: 23271622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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: ECHELON CATHETER (NON-STRYKER); NEUROFORM ATLAS STENT (STRYKER).; NEUROFORM EZ STENT (STRYKER).; SL-10 MICROCATHETER (STRYKER).; XT-27 CATHETER (STRYKER).
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Race: Asian