MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL HELICAL 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036115150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The coil was returned with the microcatheter used during the procedure.Analysis of the returned device revealed that the main coil had detached/separated via a physical break at the main coil junction.In addition the coil was heavily stretched and was protruding from both ends of the introducer sheath.The main coil suture was broken (not melted).The delivery wire was kinked/bent likely due to handling.Functional testing could not be performed due to the condition of the device.Information available indicated that coil was confirmed to be in good condition prior to use, and that the patient¿s anatomy was severely tortuous.The returned microcatheter was noted to have slight damage to the distal end.It is probable that the damage to the distal end of the microcatheter shaft was caused as a result of the tortuous anatomy ultimately contributing to the damages observed to the main coil during the clinical procedure.An assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device revealed that the main coil had detached/separated from the delivery wire.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL HELICAL 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6168675
• Report Number: 3008881809-2016-00302
• Device Sequence Number: 1111129
• Product Code: HCG
• UDI-Device Identifier: 07613327004571
• UDI-Public: (01)07613327004571(17)180731(10)18510011
• 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): 07/12/2016

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: 07/31/2018
• Device Catalogue Number: M0036115150
• Device Lot Number: 18510011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/12/2016
• 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: EXCELSIOR SL1018 (STRYKER)