MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 22MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036182250
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
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 main coil proximal end was within the catheter hub and the main coil was prematurely detached/ separated due to a physical break at the main coil junction.In addition, blood was also noted in the hub.Functional testing could not be performed due to the condition of the returned device.Additional information reported that the device was confirmed to be in good condition prior to use.The presence of blood on the device indicates insufficient flush though this cannot be conclusively determined.Based on the information currently available and the device inspection, it is probable that the coil was damaged during advancement causing the as reported event.An assignable cause of procedural factors will be assigned to the analysed ¿main coil prematurely detached/separated inside patient' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.
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 XXL 360 22MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6942493
• Report Number: 3008881809-2017-00438
• Device Sequence Number: 1223744
• Product Code: HCG
• UDI-Device Identifier: 07613327128369
• UDI-Public: (01)07613327128369(17)191031(10)19380822
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 10/11/2017

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 Model Number: M0036182250
• Device Catalogue Number: M0036182250
• Device Lot Number: 19380822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1