MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
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 inspection, the subject coil delivery wire was found kinked/bent and broken/fractured.The main coil was also noted to be kinked/bent.During functional testing, resistance was encountered when advancing the coil through the introducer sheath.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 coil delivery wire was kinked/bent and broken.The main coil was also kinked/bent and was causing friction in the introducer sheath.The as reported can be confirmed.An assignable cause of procedural factors was assigned to the as reported issue coil in catheter friction, as well as the as analyzed issues main coil kinked/bent and coil introducer sheath friction, as it 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 as analyzed issues coil delivery wire kinked/bent and coil delivery wire broken/fractured during use was assigned handling damage as it appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
Analysis of the returned device found that the subject coil delivery wire was noted to be broken/fractured.There was no clinical consequences to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 2MM X 3CM
• 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: 11963104
• Report Number: 3008881809-2021-00232
• Device Sequence Number: 4414897
• Product Code: HCG
• UDI-Device Identifier: 04546540675835
• UDI-Public: 04546540675835
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/08/2021

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: 02/18/2023
• Device Model Number: M0035422030
• Device Catalogue Number: M0035422030
• Device Lot Number: 22150614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR