MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that when the subject device (coil) was placing, the non stryker microcatheter was kicked back repeatedly, and the subject coil was winded up inside other company microcatheter.At that time surgeon pointed out that he could not push the subject coil.Since he was able to retract the subject coil, it was retracted and found out that the subject coil was detached from the coil junction part.The subject coil was exchanged with other company one.The procedure continued and completed without problem.There were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that when the subject device (coil) was placing, the non stryker microcatheter was kicked back repeatedly, and the subject coil was winded up inside other company microcathter.At that time surgeon pointed out that he could not push the subject coil.Since he was able to retract the subject coil, it was retracted and found out that the subject coil was detached from the coil junction part.The subject coil was exchanged with other company one.The procedure continued and completed without problem.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned, therefore physical and functional tests could not be performed.In the case of this complaint, it is most likely that the device encountered difficulties while inserting into microcatheter due to intermittent flush maintained during the procedure, as per device directions for use (dfu) maintaining continuous flush throughout the procedure is a critical requirement as lack of it can lead to friction or other related difficulties " main coil tangled, coil in catheter friction and main coil prematurely detached or separated inside patient".An assignable cause of ¿user error¿ will be assigned to the reported event, 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.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8942543
• Report Number: 3008881809-2019-00254
• Device Sequence Number: 11287577
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• 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): 09/16/2019

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: 02/09/2022
• Device Catalogue Number: M0036181040
• Device Lot Number: 21209162
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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: MARVEL HFMICROCATHETER; MICROCATHETER (4F) (NON STRYKER)
• Patient Age: 70 YR