MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
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.As per the additional information the device was confirmed to be in good condition during preparation/prior to use on the patient and it was prepared as per the dfu.As the device was not returned for analysis, and a review and analysis of all available information fails to indicate an assignable cause, or a probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure subject coil was attempted to insert.Physician then noted that the subject device was stretched and proceeded to use a snare device to remove subject coil.The physician replaced it with a new device, and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 10901640
• Report Number: 3008881809-2020-00365
• Device Sequence Number: 11096856
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• 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
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 21491501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/25/2020
• 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: SNARE DEVICE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention