MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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 embolization case from the coronary artery to the pulmonary artery the micro catheter was guided to the occlusion site and the resistance was felt while advancing the subject coil out of the micro catheter tip.While the physician tried to remove the subject coil from the micro catheter, it detached prematurely inside the micro catheter.So it was taken out of the anatomy along with the micro catheter.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 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.It was reported that during the procedure, the subject coil prematurely detached inside the microcatheter.Additional information provided by the customer indicated that there was no allegation against the microcatheter, resistance was felt near the tip of the microcatheter, and continuous flush was not set up and maintained throughout the clinical procedure.In the case of this complaint, it is most likely that the device encountered difficulties while advancing in the microcatheter due to a lack of continuous flush which resulted in premature detachment when the coil was manipulated against resistance.Per the dfu, "in order to achieve optimal performance of the detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil." an assignable cause of use error will be assigned to this complaint, as the investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during the embolization case from the coronary artery to the pulmonary artery the micro catheter was guided to the occlusion site and the resistance was felt while advancing the subject coil out of the micro catheter tip.While the physician tried to remove the subject coil from the micro catheter, it detached prematurely inside the micro catheter.So it was taken out of the anatomy along with the micro catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11729470
• Report Number: 3008881809-2021-00179
• Device Sequence Number: 3647139
• Product Code: HCG
• UDI-Device Identifier: 07613327466379
• UDI-Public: 07613327466379
• 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): 07/21/2021

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: 01/05/2023
• Device Model Number: M0036180520
• Device Catalogue Number: M0036180520
• Device Lot Number: 22038104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN)