MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035425150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.The device was returned and the lot number was confirmed from the packaging returned with the device.During visual inspection, subject coil delivery wire was seen to be kinked bent.The main coil was not returned and was seen to be detached.Functional testing was not carried out due to the damage to the subject device.The as reported events can be confirmed based on this as it can be presumed that friction was felt and the main coil was being advanced and detached.The as reported as well as the as analyzed events will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The coil delivery wire was seen to be kinked bent.It can be presumed it was caused by handling of the device when friction was felt.This as analyzed event will be assigned handling damage as it appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.
Event or Problem Description
It was reported that during the procedure, physician reported that the subject coil had elasticed and was difficult to push.Analysis of the returned subject coil revealed that the device had prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 ULTRA 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11711256
• Report Number: 3008881809-2021-00176
• Device Sequence Number: 4331050
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 04/22/2021

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: 01/31/2021
• Device Model Number: M0035425150
• Device Catalogue Number: M0035425150
• Device Lot Number: 20235824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR