MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101650
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection performed on the returned device revealed that the main coil was severely stretched and detached from the delivery wire and the coil suture was found damaged.In addition, the coil delivery wire was found to be kinked/bent.Functional testing was not required as the reported defects were confirmed.Based on the information provided in the complaint and the device analysis, it is most likely that the coil encountered resistance from procedural factors when it was retracted into the microcatheter which then caused it to further stretch, resulting in suture damage and mechanically detachment during manipulation.Therefore, a probable cause of procedural factors will be assigned to the as reported events.It can be presumed that the delivery wire was kinked during the procedure as excessive force may have been applied at the proximal end of the device during retraction.Therefore, a probable cause of handling damage will be assigned.The reported event is covered in the device directions for use (dfu).Also, 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.Based on the investigation results and available information an assignable cause of procedural factors will be assigned to the alleged complaint.
Event or Problem Description
It was reported that during the procedure, the subject coil stretched when the physician tried to retrieve the coil out of the aneurysm.While removing, the subject coil detached inside the microcatheter.The devices were replaced and the procedure was completed successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 16MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9897338
• Report Number: 3008881809-2020-00078
• Device Sequence Number: 19530415
• Product Code: HCG
• UDI-Device Identifier: 04546540711304
• UDI-Public: 04546540711304
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• 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): 03/30/2020

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: 07/16/2022
• Device Model Number: M0036101650
• Device Catalogue Number: M0036101650
• Device Lot Number: 21593980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1