MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK MATRIX2 ULTRASOFT SR 3MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M003497320SR0
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported resistance was felt, the coil stretched and was removed from the patient with a snare device.There was no clinical consequence to the patient.
Event or Problem Description
It was reported resistance was felt, the coil stretched and was removed from the patient with a snare device.There was no clinical consequence to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed that the introducer sheath was not returned.The proximal end of the main coil was noted to be extensively stretched.Functional testing could not be performed due to the damaged condition of the returned coil.Information available indicated that the device was confirmed to be in good condition prior to use, the device was prepared as per the dfu.It is probable that the coil was damaged as a result of the friction experienced during advancement from the distal end of the microcatheter causing the coil to stretch and the subsequent medical intervention with the microsnare.It is likely that the main coil was damaged during use thus limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of component failure has been assigned to this investigation.

• Brand Name: MATRIX2 ULTRASOFT SR 3MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7932535
• Report Number: 3008881809-2018-00430
• Device Sequence Number: 1936979
• Product Code: HCG
• UDI-Device Identifier: 04546540691699
• UDI-Public: 04546540691699
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K050700
• 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): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: M003497320SR0
• Device Lot Number: 19350395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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: AGILITY14 STANDARD MICROCATHETER (CODMAN); SNARE (MEDTRONIC)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR