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

Model Number	M0035432080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the proximal contact wire was intact but the coil delivery wire was kinked/bent.The distal tip was found to be intact and the main coil was returned manually detached.The main coil was stretched and there was procedural fluid on the coil.Functional testing could not be performed since the main coil was returned manually detached.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.It was reported that the coil could not be detached during the procedure.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the rhv was sufficiently tightened prior to detachment, and there was no allegation against the inzone used during the procedure.Although functional testing could not be performed since the main coil was returned manually detached, the damage to the delivery wire is indicative of the reported event.It is likely that the coil delivery wire was damaged due to handling of the device during the clinical procedure resulting in the failed detachment.Therefore, an assignable cause of handling damage will be assigned to the main coil failed/unable to detach and coil delivery kinked/bent.The stretching on the main coil likely occurred during manipulation of the coil in the microcatheter.It is possible that friction may have been encountered during the procedure causing the main coil to stretch and then prematurely detach when retracting the coil against resistance.An assignable cause of procedural factors will be assigned to the main coil stretched main coil prematurely detached/separated during use since these issues appear to be associated with a product that met 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
The coil (subject device) was returned for analysis and the device investigation revealed that the subject coil prematurely detached/separated during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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
• MDR Report Key: 11283816
• Report Number: 3008881809-2021-00067
• Device Sequence Number: 11832171
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: 04546540676023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/05/2021

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: 06/03/2023
• Device Model Number: M0035432080
• Device Catalogue Number: M0035432080
• Device Lot Number: 22302567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1