MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed the coil was kinked, stretched and was broken, most likely during manipulation of the coil against originally reported friction inside the microcatheter.There was damage to suture as well.Functional testing could not be performed due to the damaged condition of the returned device.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 is probable there was friction met inside the microcatheter due to some procedural/anatomical factors encountered during use, therefore, an assignable cause of procedural factors will be assigned to the investigation.
Event or Problem Description
Analysis of the returned device revealed the main coil had fractured during use.There was no clinical consequence to the patient.

• Brand Name: TARGET 360 NANO 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8672603
• Report Number: 3008881809-2019-00159
• Device Sequence Number: 2087459
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: 07613252600305
• Combination Product (Y/N): N
• 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): 06/05/2019

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: 10/16/2021
• Device Catalogue Number: M0035442540
• Device Lot Number: 20943902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 60