MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, when the coil (subject device) was inserting into the non-stryker microcatheter, the resistance was encountered at the shaft.The main coil (subject device) was prematurely detached inside the microcatheter.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, it is unknown if continuous flush was set up and maintained throughout the clinical procedure, no excessive force was applied while advancing the coil.The resistance was felt at the shaft.The coil was advanced slowly and gently.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during procedure, when the coil (subject device) was inserting into the non-stryker microcatheter, the resistance was encountered at the shaft.The main coil (subject device) was prematurely detached inside the microcatheter.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET XL 360 SOFT 2MM X 3CM
• 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: 11951908
• Report Number: 3008881809-2021-00226
• Device Sequence Number: 4243323
• Product Code: HCG
• UDI-Device Identifier: 07613327128321
• UDI-Public: 07613327128321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/30/2021

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: 02/10/2023
• Device Model Number: M0036122030
• Device Catalogue Number: M0036122030
• Device Lot Number: 22104227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: MICROCATHETER (ASAHI INTEC / TELLUS); MICROCATHETER (ASAHI INTEC / TELLUS)