MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180820
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
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 a neurovascular procedure, the subject coil got prematurely detached during use.The subject coil was retrieved out of the patients body along with the microcatheter.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that, during a neurovascular procedure, the subject coil got prematurely detached during use.The subject coil was retrieved out of the patients body along with the microcatheter.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B1: adverse event/product problem ¿ corrected - no ¿product problem¿.H1: type of reportable event ¿ corrected - no ¿malfunction¿.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Upon visual/microscopic inspection of the returned subject coil the coil proximal contact was seen to be kinked/bent, the coil delivery wire was noted to be kinked/bent, the main coil was seen to be attached to the detachment zone, the main coil was seen to be severely stretched as per photo and the coil suture was seen to be broken.Functional inspection was not required.The reported main coil prematurely detached/separated during use was not confirmed during analysis.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 event 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.Additional information provided by the customer is 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.During analysis it was noted, the main coil was severely stretched but not detached or separated from the delivery wire.The coil proximal contact and delivery wire were both seen to be kinked/bent.An assignable cause of not confirmed will be assigned to the as reported 'main coil prematurely detached/separated during use' as the event was not confirmed during the analysis only the coil was severely stretched from the detachment zone.An assignable cause of procedural factors will be assigned to the as analyzed main coil stretched and nv - main coil suture damaged' as these defects appears to be associated with a product that met stryker 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 the as analyzed 'coil proximal contact kinked/bent' and 'coil delivery wire kinked/bent' as the issue is due to handling of the product or portion of the product during the clinical 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 XXL 360 8MM 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: 17151959
• Report Number: 3008881809-2023-00304
• Device Sequence Number: 6021024
• Product Code: HCG
• UDI-Device Identifier: 07613327466416
• UDI-Public: 07613327466416
• 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): 08/25/2023

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: 11/30/2024
• Device Model Number: M0036180820
• Device Catalogue Number: M0036180820
• Device Lot Number: 21979298R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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: TRANSIT MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown