MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122030
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
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 the procedure when the physician was repeatedly inserting and removing the subject coil in and out of the microcatheter to place to the target area, the middle part of the coil subject device was not visible and on retrieval the subject coil was found stretched.The physician replaced it with a new device and continued the procedure 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.The product was not returned for analysis therefore, visual and functional testing was not 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.Additional information received indicated that there was friction or resistance while the coil was advancing in the introducer sheath which may have damaged the coil.Also additional information received indicated that continuous flush was not maintained throughout the procedure, as per the dfu continuous flush is required during the procedure.An assignable cause of user error will be assigned to this complaint 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.
Event or Problem Description
It was reported that during the procedure when the physician was repeatedly inserting and removing the subject coil in and out of the microcatheter to place to the target area, the middle part of the coil subject device was not visible and on retrieval the subject coil was found stretched.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 2MM X 3CM
• 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: 13387370
• Report Number: 3008881809-2022-00041
• Device Sequence Number: 4935769
• Product Code: HCG
• UDI-Device Identifier: 07613327128321
• UDI-Public: 07613327128321
• 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): 04/25/2022

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: 08/15/2024
• Device Model Number: M0036122030
• Device Catalogue Number: M0036122030
• Device Lot Number: 23100857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown