MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During analysis, the delivery wire was found to be kinked at one location and was fractured at the proximal end of the introducer sheath.Functional testing could not be performed due to the condition of the returned device.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained during the clinical procedure.It was stated during good faith effort indicated that the introducer sheath was removed once the coil was fully inserted into the microcatheter.However, the coil was returned for analysis inside an introducer sheath.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 and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the reported event 'coil in catheter friction'.An assignable cause of handling damage will be assigned to the assignable codes 'coil delivery wire kinked/bent' and 'coil delivery wire broken/fractured during use' as it is most likely that this damage to the delivery wire occurred due to handling of the device during use.
Event or Problem Description
It was reported that during one ba aneurysm case, when using the subject coil to finish, the coil (subject device) could not be pushed at distal of microcatheter even after several tries.The operator replaced the subject coil with another brand and continued the procedure successfully without clinical consequences to the patient.Analysis of the returned device found the coil delivery wire broken/fractured.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• 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: 12229299
• Report Number: 3008881809-2021-00313
• Device Sequence Number: 4490841
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• 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): 07/26/2021

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: 01/19/2022
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 21162153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/27/2021
• 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: COSMOS (UNKNOWN MANUFACTURER)
• Patient Age: 57 YR
• Patient Weight: 79