MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 360 7MM X 20CM SR; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M003346720SR0
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the subject coil got deployed in the microcatheter itself and the coil was removed.The procedure was completed with another of the same device without clinical consequences to the patient.
Event or Problem Description
It was reported that the subject coil got deployed in the microcatheter itself and the coil was removed.The procedure was completed with another of the same device without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed the main coil had detached;however, it could not be confirmed if the coil had detached 'itself'.No anomalies were noted on the introducer sheath and the delivery wire.Functional testing could not be performed due to the condition of the returned device.In the case of this complaint, it was reported that: 'the coil got deployed in the micro catheter itself'.The additional information states that friction was encountered between the coil and the catheter during the procedure.Based on the investigation results and available information, an assignable cause of procedural factors - cause traced to component failure will be assigned to this investigation.The issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device directions for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.

• Brand Name: GDC-10 360 7MM X 20CM SR
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7903851
• Report Number: 3008881809-2018-00414
• Device Sequence Number: 169962
• Product Code: HCG
• UDI-Device Identifier: 04546540689696
• UDI-Public: 04546540689696
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042539
• 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,Followup
• Report Date (Section B): 11/12/2018

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: 10/31/2019
• Device Catalogue Number: M003346720SR0
• Device Lot Number: 19439457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON MICROCATHETER (MEDTRONIC)