MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during isolation of a pseudosplenic aneurysm procedure, when inserted the coil (subject device) into a non-stryker microcatheter, carnelian hf, and when pushing and pulling was performed to engage with the vessel repeatedly, the coil (subject device) got prematurely detached (detached position is unknown).Therefore, the coil (subject device) retrieved with the entire microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during isolation of a pseudosplenic aneurysm procedure, when inserted the coil (subject device) into a non-stryker microcatheter, carnelian hf, and when pushing and pulling was performed to engage with the vessel repeatedly, the coil (subject device) got prematurely detached (detached position is unknown).Therefore, the coil (subject device) retrieved with the entire microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire as found to be kinked/bent, the main coil was found to be severely stretched, and the main coil was found to be stuck in the catheter.During a functional test the reported ¿main coil prematurely detached/separated during use¿ was unable to perform due to condition of device and the reported ¿device difficulty engaging target vessel¿ could not be confirmed during analysis as the event is procedure/patient related.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 ¿main coil prematurely detached/separated during use¿ was not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed, and the coil delivery wire was found to be kinked/bent.The man coil was found to be severely stretched.The main coil was found to be stuck in the catheter.An assignable cause of not confirmed will be assigned to the reported ¿main coil prematurely detached/ separated during use¿ and ¿device difficulty engaging target vessel¿ as the issue was not confirmed during device analysis.An assignable cause of handing damage will be assigned to the as analyzed code 'coil delivery wire kinked/bent', ¿main coil stretched¿ and ¿coil jammed¿ as this defect 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.

• Brand Name: TARGET XL 360 SOFT 2MM X 6CM
• 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: 16209964
• Report Number: 3008881809-2023-00026
• Device Sequence Number: 12116595
• Product Code: HCG
• UDI-Device Identifier: 07613327128260
• UDI-Public: 07613327128260
• 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): 02/17/2023

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: 07/02/2025
• Device Model Number: M0036122060
• Device Catalogue Number: M0036122060
• Device Lot Number: 23751435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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: CARNELIAN HF MICROCATHETER (NON - STRYKER); TARGET COILS (STRYKER)
• Patient Sex: Unknown