MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036181450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the coil (subject device) was retrieved from the patient it detached prematurely.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, when the coil (subject device) was retrieved from the patient it detached prematurely.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the subject coil was seen to be detached from the delivery wire and there was blood seen within the introducer sheath.The coil delivery wire was seen to be kinked at the proximal contact junction.Functional testing was not performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, 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 reported event of the main coil prematurely detached/separated during use can be confirmed and 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 analyzed event of the 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.

• Brand Name: TARGET XXL 360 14MM X 50CM
• 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: 13151139
• Report Number: 3008881809-2022-00001
• Device Sequence Number: 5411650
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: 07613327128383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 03/31/2022

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: 09/08/2023
• Device Model Number: M0036181450
• Device Catalogue Number: M0036181450
• Device Lot Number: 22432065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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
• Patient Sex: Unknown