MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the device revealed that the delivery wire was broken/fractured during use and the main coil was kinked./bent during functional testing, the resistance was encountered in the 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 damage noted to the device would be indicative of the as reported defect.The as reported 'coil in catheter friction' and as analysed ¿ coil introducer sheath friction¿ and ¿ main coil kinked/bent¿ will be assigned procedural factors as these 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.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Because this 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, a probable cause of handling damage will be assigned to the as analysed 'coil delivery wire broken/fractured during use¿.
Event or Problem Description
Analysis of the returned device found that the delivery wire was broken during use.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 4MM X 6CM
• 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: 11509810
• Report Number: 3008881809-2021-00127
• Device Sequence Number: 11784118
• Product Code: HCG
• UDI-Device Identifier: 04546540675910
• UDI-Public: 04546540675910
• 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): 03/17/2021

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: 03/24/2023
• Device Model Number: M0035424060
• Device Catalogue Number: M0035424060
• Device Lot Number: 22204241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR