MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection it was found that only the main coil part of the device returned.It was kinked bent and had detached.Functional testing was not carried out due to damage noted to the device.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.It was reported that the subject coil was stretched in the microcatheter during use and was not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, the coil was not advanced or retracted with force, and the damage was noted when advancing the coil.During analysis, the main coil was found to be kinked/bent.In the case of this complaint, it is probable that the coil was kinked during manipulation inside the microcatheter causing difficulty advancing.When the damaged coil was retracted, it then likely detached prematurely in the microcatheter.An assignable cause of procedural factors will be assigned to the as analyzed event since these issues appear 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 and/or anatomical factors during use.
Event or Problem Description
The device was returned for analysis and the investigation revealed that the coil (subject device) prematurely detached during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• 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: 11497048
• Report Number: 3008881809-2021-00120
• Device Sequence Number: 3971743
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: 04546540676511
• 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): 03/16/2021

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: 08/25/2021
• Device Model Number: M0035475200
• Device Catalogue Number: M0035475200
• Device Lot Number: 20824096
• 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: 02/18/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 59