MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4.5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424510
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the coil had prematurely detached inside the microcatheter and had remained stuck, during preparation of the device.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that the coil had prematurely detached inside the microcatheter and had remained stuck, during preparation of the device.The coil was retrieved along with the microcatheter.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.Visual inspection revealed that the proximal contact wire was kinked/bent.The coil delivery wire, distal tip and the main coil were found to be intact.During functional testing, it was noted that the main coil was advanced from the introducer sheath without issues and was not detached.The reported defect was not confirmed based on the analysis.Therefore, an assignable cause of "not confirmed" has been assigned to the reported event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 ULTRA 4.5MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8732830
• Report Number: 3008881809-2019-00181
• Device Sequence Number: 13900160
• Product Code: HCG
• UDI-Device Identifier: 04546540714763
• UDI-Public: 04546540714763
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K153658
• 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): 08/26/2019

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: 11/26/2021
• Device Catalogue Number: M0035424510
• Device Lot Number: 21046384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: SL-10 MICROCATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Age: 44 YR
• Patient Weight: 59