MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was found mechanically detached from the delivery wire and the main coil was not returned.In addition, the delivery wire was kinked due to handling.Functioning test could not be performed due to the condition of the returned device.In the case of this complaint it is most likely that the coil failed to detach during the procedure due to some procedural factors encountered, and on removal of the device from the patient became detached fully within the micro catheter.This complaint appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu (direction for use), but performance was limited due to procedural factors during use.Therefore a probable cause of procedural factors will be assigned to the reported and analyzed main coil defects.
Event or Problem Description
During the analysis of the returned device, it was revealed that the main coil was prematurely detached inside the patient.No clinical consequences reported to the patient.

• Brand Name: TARGET HELICAL NANO 2 MM X 3 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9042026
• Report Number: 3008881809-2019-00274
• Device Sequence Number: 2181657
• Product Code: HCG
• UDI-Device Identifier: 07613252600367
• UDI-Public: 07613252600367
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/13/2019

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: 09/02/2021
• Device Catalogue Number: M0035452030
• Device Lot Number: 20829273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR