MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036123090
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned with the introducer sheath.Visual inspection of the device revealed that the delivery wire was kinked, the main coil had prematurely detached/separated (physical break at detachment zone), stretched out and there was damage to the main coil suture.Functional testing could not be performed due to the damaged condition of the returned coil.The device was confirmed to be in good condition prior to use.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device noted that the main coil had prematurely detached/separated.No consequences to the patient were reported.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6342596
• Report Number: 3008881809-2017-00049
• Device Sequence Number: 19132844
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: (01)07613327128284(17)190131(10)18844446
• Combination Product (Y/N): N
• PMA/510(K) Number: K123377
• 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
• Report Date (Section B): 02/19/2017

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: 01/31/2019
• Device Catalogue Number: M0036123090
• Device Lot Number: 18844446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 02/19/2017
• 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 ID:0.017INCH (TOKAI MEDICAL)
• Patient Age: 69 YR