MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during a coil embolization procedure, the subject coil's delivery wire fractured when delivering to the patient.The physician replaced it with a new device and finished the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the coil proximal contact was detached at the proximal contact bond; likely due to handling as the 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.Functional inspection could not be performed due to the condition of the returned device.Based on the information currently available, 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 reported event will not be confirmed as the damage noted to the device would be indicative of the as reported defect.The coil proximal contact was seen to be detached which may have been interpreted by the physician that the coil delivery wire to be broken.The manufacturer has reviewed all information and determined this event no longer meets the requirement of a reportable event for the device in question.
Event or Problem Description
It was reported that during a coil embolization procedure, the subject coil's delivery wire fractured when delivering to the patient.The physician replaced it with a new device and finished the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8819783
• Report Number: 3008881809-2019-00214
• Device Sequence Number: 320305
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 09/26/2019

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: 06/13/2021
• Device Catalogue Number: M0035474100
• Device Lot Number: 20608906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 56 YR