MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
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 attempted to place and re-positioned several times and the subject coil became stretched under fluoroscopy.The subject coil delivery wire was found to be fractured approximately 3cm from the coil junction during retraction.Physician used a snare device to retrieve the fractured portion from the aneurysm.The procedure was completed successfully with a new device and no clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, the subject coil was attempted to place and re-positioned several times and the subject coil became stretched under fluoroscopy.The subject coil delivery wire was found to be fractured approximately 3cm from the coil junction during retraction.Physician used a snare device to retrieve the fractured portion from the aneurysm.The procedure was completed successfully with a new device and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.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.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

• Brand Name: TARGET 360 SOFT 6MM X 20CM
• 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: 10022572
• Report Number: 3008881809-2020-00130
• Device Sequence Number: 14079082
• Product Code: HCG
• UDI-Device Identifier: 04546540676542
• UDI-Public: 04546540676542
• Combination Product (Y/N): N
• 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): 05/27/2020

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: 12/02/2021
• Device Model Number: M0035476200
• Device Catalogue Number: M0035476200
• Device Lot Number: 21059857
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1