MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180820
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
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 complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 to the reported coil in catheter friction and main coil prematurely detached/separated during use.Subject device is not available.
Event or Problem Description
It was reported that during the procedure, the subject coil was inserted into a micro catheter and resistance was encountered at the distal part.The physician pulled the subject coil and it prematurely detached inside the micro catheter.The subject coil and micro catheter were removed and the procedure was completed without clinical consequences to the patient.

• Brand Name: TARGET XXL 360 8MM 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: 10480750
• Report Number: 3008881809-2020-00249
• Device Sequence Number: 2815968
• Product Code: HCG
• UDI-Device Identifier: 07613327466416
• UDI-Public: 07613327466416
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K161429
• 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): 09/01/2020

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: 06/22/2022
• Device Model Number: M0036180820
• Device Catalogue Number: M0036180820
• Device Lot Number: 21543835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/01/2020
• 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: MICRO CATHETER (UNKNOWN)