MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035479300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure, while pushing the coil into the microcatheter, there was a lot of friction felt.The user pulled back the coil and found it detached in the hub of the microcatheter.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during procedure, while pushing the coil into the microcatheter, there was a lot of friction felt.The user pulled back the coil and found it detached in the hub of the microcatheter.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.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.Visual inspection was performed on the returned device and it was observed that the main coil was kinked, stretched, and detached from the pusher wire at the detachment area.Functional test could not be completed as the coil was detached from the pusher wire on return.The damage noted to the device would be indicative of the as reported defect.Therefore, an assignable cause of procedural factors will be assigned to reported and analyzed issues as these defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.

• Brand Name: TARGET 360 SOFT 9MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9148921
• Report Number: 3008881809-2019-00300
• Device Sequence Number: 11418984
• Product Code: HCG
• UDI-Device Identifier: 04546540676627
• UDI-Public: 04546540676627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 12/18/2019

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: 06/30/2020
• Device Catalogue Number: M0035479300
• Device Lot Number: 19858257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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: MICROCATHETER (UNKNOWN)