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

Model Number	M0036126200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the coil (subject device) was detached prematurely in the catheter.The procedure was completed successfully.The patients medical condition was good.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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.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.Additional information received from the customer indicated that continuous flush was maintained throughout the procedure.The product expiry date was found to be out of date at the time of the procedure.The expirty date was the 30 jun 2020 and the procedure was reported to have taken place on the (b)(6) 2020.The dfu states not to use expired devices.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 as reported.Device was not returned for evaluation.
Event or Problem Description
It was reported that during the procedure the coil (subject device) was detached prematurely in the catheter.The procedure was completed successfully.The patients medical condition was good.There were no clinical consequences to the patient.

• Brand Name: TARGET XL 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 ; EI NA
• MDR Report Key: 10590544
• Report Number: 3008881809-2020-00276
• Device Sequence Number: 2822361
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• 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): 11/10/2020

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: 06/30/2020
• Device Model Number: M0036126200
• Device Catalogue Number: M0036126200
• Device Lot Number: 19839276
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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: SL-10 CATHETER (STRYKER).