MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036127200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal part subject main coil got stretched and the subject coil was prematurely detached in the microcatheter.The subject device was replaced; the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem section h1 type of reportable event - corrected - no malfunction h3 device evaluated by mfg: updated due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection it was found that, the subject coil delivery wire was found to be kinked/bent.The main coil was found to be stretched, and the main coil was found to be kinked/bent.Main coil suture was found to be damaged.In functional test, the main coil stretched was confirmed from the visual inspection, main coil prematurely detached/separated during use was not confirmed during analysis.Device interaction with another device was not confirmed during analysis because the reported event relates to the procedural event and can't be recreated.The reported event is covered in the device direction 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 code main coil stretched was confirmed.The reported main coil prematurely/separated during use and device interaction with another device was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the main coil got stretched.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.The damage occurred at the time of first coil insertion.There was no friction noted while the coil was advancing the introducer sheath.When advancing the coil, the physician proceeded slowly and carefully without excessive force.The tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter.The product was returned for analysis and the coil delivery wire, and the main coil was found to be kinked/bent.The main coil was found to be stretched, and the suture was found to be damaged.The reported main coil prematurely detached/separated during use was not confirmed during analysis.The reported device interaction with another device was not confirmed during analysis because the reported event relates to the procedural event and could not be recreated.Hence an assignable cause of not confirmed will be assigned to these reported codes.An assignable cause of procedural factors will be assigned to as reported as well as analyzed main coil stretched and analyzed codes main coil kinked/bent and main coil suture damaged complaint appears to be associated with a product that met company¿s design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of handling damage will be assigned to as analyzed coil delivery wire kinked/bent this complaint appears to be associated with handling of the product or portion of the product during the procedure.¿the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.¿.
Event or Problem Description
It was reported that the distal part subject main coil got stretched and the subject coil was prematurely detached in the microcatheter.The subject device was replaced; the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject coil was returned for analysis.The coil was examined, and it was discovered that the reported event of the subject main coil being prematurely detached during the procedure was not confirmed.The returned main coil was found to be stretched, kinked/bent, suture damaged and coil delivery wire was kinked/bent.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 7MM X 20CM
• 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: 21938340
• Report Number: 3008881809-2025-00241
• Device Sequence Number: 5343473
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: (01)07613327004632(17)291209(10)25349601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242243
• 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): 06/17/2025

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 Catalogue Number: M0036127200
• Device Lot Number: 25349601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown