MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that when advancing the subject 5th coil through the microcatheter, resistance was encountered and the coil got stuck; therefore, the coil was removed.Upon removal from the microcatheter, the subject coil was broken.Another coil was used to complete the procedure.No patient consequences reported due to this event.
Additional Manufacturer Narrative
Expiration date: added.Manufacturing date: added.The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.The reported issue is covered in the device directions for use.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 product was not returned, however, additional information indicated that intermittent flush was used during the procedure and it is likely that the failure to apply continues flush may have caused the reported friction leading to the reported fracture of the main coil.As per the dfu "warning: in order to achieve optimal performance of the target 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 stryker neurovascular 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." the investigation confirmed that there was an act or omission of an act that could have resulted in a different medical device response than intended by the manufacturer and/or expected by the user.Therefore, an assignable cause of user error has been assigned to this event.
Event or Problem Description
It was reported that when advancing the subject 5th coil through the microcatheter, resistance was encountered and the coil got stuck; therefore, the coil was removed.Upon removal from the microcatheter, the subject coil was broken.Another coil was used to complete the procedure.No patient consequences reported due to this event.

• Brand Name: TARGET XXL 360 20MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9079072
• Report Number: 3008881809-2019-00279
• Device Sequence Number: 2976323
• Product Code: HCG
• UDI-Device Identifier: 07613327128345
• UDI-Public: 07613327128345
• Combination Product (Y/N): N
• 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): 10/30/2019

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: 02/17/2022
• Device Catalogue Number: M0036182050
• Device Lot Number: 21234614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: PROGRATE MICROCATHETER (TERUMO MEDICAL)