MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil prematurely detached in the hub of the microcatheter, inside the patient.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection was performed on the returned sample and it was observed the mail coil was both kinked and stretched.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.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.The reported event was confirmed.It is most probable that procedural or anatomical factors encountered during the procedure contributed to the main coil prematurely detaching inside the patient, therefore, a cause of procedural factors will be assigned to the investigation.
Event or Problem Description
It was reported that the coil prematurely detached in the hub of the microcatheter, inside the patient.There were no clinical consequences reported due to this event.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8773266
• Report Number: 3008881809-2019-00197
• Device Sequence Number: 1978616
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• 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): 07/30/2019

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: 02/17/2022
• Device Catalogue Number: M0035423100
• Device Lot Number: 21230476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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 MANUFACTURER); MICROCATHETER (UNKNOWN MANUFACTURER)