MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 24MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that resistance was encountered while advancing the coil(subject device) into the other company micro catheter, and the subject coil was difficult to be placed into the aneurysm at the internal iliac artery, and when the physician attempted to retract the subject coil, it got stretched and then it prematurely detached inside the micro catheter inside the patient's anatomy during the procedure.The physician retracted the detached coil and microcatheter from the vessel and the same micro catheter was used again to complete the procedure successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a 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.Additional information indicated that intermittent flush maintained during the procedure.It is most likely that the subject device encountered difficulties while inserting into microcatheter due to intermittent flush, as per dfu maintaining continuous flush throughout the procedure is a critical requirement as lack of it can lead to friction or other related difficulties.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.The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that resistance was encountered while advancing the coil(subject device) into the other company micro catheter, and the subject coil was difficult to be placed into the aneurysm at the internal iliac artery, and when the physician attempted to retract the subject coil, it got stretched and then it prematurely detached inside the micro catheter inside the patient's anatomy during the procedure.The physician retracted the detached coil and microcatheter from the vessel and the same micro catheter was used again to complete the procedure successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XXL 360 24MM 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: 9335721
• Report Number: 3008881809-2019-00348
• Device Sequence Number: 1849979
• Product Code: HCG
• UDI-Device Identifier: 07613327128376
• UDI-Public: 07613327128376
• 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): 12/10/2019

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: 08/31/2020
• Device Catalogue Number: M0036182450
• Device Lot Number: 19937395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: MASTER HF MICROCATHETER(UNKNOWN); MASTER HF MICROCATHETER(UNKNOWN)