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

Model Number	M0036180520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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.During visual/microscopic inspection the coil delivery wire was noted to be kinked/bent.Main coil was noted to be detached.Dried procedural fluid was noted.Functional inspection could not perform as main coil was detached and not returned.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 delivery wire was found to be kinked/bent.The main coil was found to be detached from the delivery wire.The reported as reported codes coil difficult to remove/withdraw from catheter, coil jammed and mail coil stretched were not confirmed.An assignable cause of procedural factors will be assigned to as analyzed code main coil prematurely detached/separated during use as this 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 and an assignable cause of handling damage will be assigned to the as analyzed code coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use.
Event or Problem Description
Analysis of the returned device found that the main coil prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET XXL 360 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: 12436933
• Report Number: 3008881809-2021-00364
• Device Sequence Number: 3392169
• Product Code: HCG
• UDI-Device Identifier: 07613327466379
• UDI-Public: 07613327466379
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 09/07/2021

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: 01/13/2023
• Device Model Number: M0036180520
• Device Catalogue Number: M0036180520
• Device Lot Number: 22062555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1