MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject coil was stretched while the physician was retracting it back into the micro catheter.The stretched part of the subject coil broke outside the aneurysm and was left inside the patient.Surgical delay of unknown time was reported during the procedure.It was reported that the patient will have to follow up for further treatment but no further information is available at the moment.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.It was reported that, the coil became stretched as they were trying to remove it and put it back in the micro catheter.Part of the coil that was stretched unraveled inside the patient.A portion of the coil was left outside the aneurysm.There was no reply to the additional information request.The device was not returned for analysis.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the procedure the subject coil was stretched while the physician was retracting it back into the micro catheter.The stretched part of the subject coil broke outside the aneurysm and was left inside the patient.Surgical delay of unknown time was reported during the procedure.It was reported that the patient will have to follow up for further treatment but no further information is available at the moment.

• Brand Name: TARGET 360 SOFT 6MM X 15CM
• 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: 11416423
• Report Number: 3008881809-2021-00111
• Device Sequence Number: 4014804
• Product Code: HCG
• UDI-Device Identifier: 04546540676535
• UDI-Public: 04546540676535
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: M0035476150
• Device Catalogue Number: M0035476150
• Device Lot Number: 21786536
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: UNKNOWN MICRO CATHETER
• Outcome Attributed to Adverse Event: Other