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

Catalog Number	M0036125150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the procedure the subject coil detached while repositioning inside the catheter.The catheter hub was cut and snare device was used to remove the subject coil from the catheter.The device was replaced and the procedure was completed successfully with no adverse consequences to the patient.
Additional Manufacturer Narrative
H3 other text : device not returned for evaluation.
Additional Manufacturer Narrative
B5 executive summary - updated.H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot 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.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 physician reported that the coil prematurely detached during repositioning the subject coil.The detachment system was not yet being used at the time of the premature detachment so it is likely that the coil physically detached due to a break.However as the coil has not been returned this cannot be confirmed.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the reported event of the main coil prematurely detached during use and coil in catheter friction.
Event or Problem Description
It was reported during the procedure the subject coil detached while repositioning inside the catheter.The catheter hub was cut and snare device was used to remove the subject coil from the catheter.The device was replaced and the procedure was completed successfully with no adverse consequences to the patient.Update: it was reported during the procedure the subject coil detached in the vessel.The catheter hub was cut and snare device was used to remove the subject coil.The device was replaced, and the procedure was completed successfully with no adverse 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18983416
• Report Number: 3008881809-2024-00125
• Device Sequence Number: 2833187
• 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,Followup
• Report Date (Section B): 05/02/2024

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: 04/18/2026
• Device Catalogue Number: M0036125150
• Device Lot Number: 24299685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female