MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 11MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035471130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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 found to be kinked/bent.The coil delivery wire was found to be broken/fractured 0.5 cm from proximal contact bond.The detachment zone was found to be intact.The main coil was found to be intact.During functional inspection main coil failed/unable to detach functional test was unable to perform due to delivery wire breakage.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.During analysis the coil delivery wire was found to be kinked/bent and broken/fractured.In the case of this complaint it is most likely that the coil got damaged during coil advancement against friction.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.Therefore, an assignable cause of procedural factors will be assigned to the as reported code main coil failed/unable to detach.The as reported & as analyzed code coil delivery wire kinked/bent and as analyzed code coil delivery wire broken/fractured during will be assigned handling damage as this complaint 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
Analysis of the returned device found that the subject coil delivery wire was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 SOFT 11MM X 30CM
• 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: 12425147
• Report Number: 3008881809-2021-00359
• Device Sequence Number: 19727983
• Product Code: HCG
• UDI-Device Identifier: 07613252192664
• UDI-Public: 07613252192664
• 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): 09/03/2021

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: 01/26/2023
• Device Model Number: M0035471130
• Device Catalogue Number: M0035471130
• Device Lot Number: 22085495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/03/2021
• 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: SL-10 MICRO CATHETER (STRYKER)
• Patient Age: 61 YR
• Patient Weight: 89