MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036124120
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during iia coil embolization procedure, the physician guided the microcatheter into the lesion and deployed the subject coil into the patient blood vessel.After repeated framing work, the subject coil was prematurely deployed inside the lumen of the microcatheter.The prematurely deployed subject coil was removed together with the microcatheter.There was no remaining coil inside the patient anatomy.The procedure was completed successfully by another method other than the coil embolization without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the device was returned together with guidewire and microcatheter.The coil delivery wire was found kinked/bent.The main coil was found detached and severely kinked/bent in a few places.The main coil was found to be stretched and it was more likely that mechanical detachment occurred.The returned guidewire and microcatheter found to be intact.Functional testing was not required because the coil was already detached 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 prior to use, the device was prepared as per the dfu.Also additional information indicated that continuous flush was not set up and maintained throughout the clinical procedure, as per the dfu continuous flush is required when delivering the main coil.The returned main coil was found to be detached.Therefore the as reported 'main coil prematurely detached/separated during use' can be confirmed.The as reported and as analyzed 'main coil prematurely detached/separated during use' as well as the as analyzed 'main coil kinked/bent' and ¿main coil stretched' will be assigned user error as the investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.The as analyzed 'coil delivery wire kinked bent' will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during iia coil embolization procedure, the physician guided the microcatheter into the lesion and deployed the subject coil into the patient blood vessel.After repeated framing work, the subject coil was prematurely deployed inside the lumen of the microcatheter.The prematurely deployed subject coil was removed together with the microcatheter.There was no remaining coil inside the patient anatomy.The procedure was completed successfully by another method other than the coil embolization without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 12677353
• Report Number: 3008881809-2021-00448
• Device Sequence Number: 11836969
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: 07613327128338
• 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): 02/17/2022

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: 05/02/2024
• Device Model Number: M0036124120
• Device Catalogue Number: M0036124120
• Device Lot Number: 22888850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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 -1018 MICROCATHETER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Sex: Unknown