MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not returned.
Event or Problem Description
It was reported that the during the coil embolization procedure, the subject coil was not passing through the distal end of microcatheter.While trying to remove the coil, it got broke inside the microcatheter.The coil was successfully removed along with the microcatheter.No clinical consequences were reported to the patient.
Event or Problem Description
It was reported that the during the coil embolization procedure, the subject coil was not passing through the distal end of microcatheter.While trying to remove the coil, it got broke inside the microcatheter.The coil was successfully removed along with the microcatheter.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device found that the coil delivery wire was kinked bent.The main coil was broken/fractured and stretched.On analysis of the catheter with this coil, the main coil was found on the catheter shaft.During functional testing the device was advanced through the introducer sheath with the friction.The as analysed defects 'main coil stretched' and 'main coil broken fractured' will be assigned an assignable cause of procedural factors as well as the as reported events/defects.The issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.The damage and friction noted to the delivery wire could have been caused when force was applied to the device when retracting back through the micro catheter.Therefore an assignable cause of handling damage will be assigned to the delivery wire kink.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8035238
• Report Number: 3008881809-2018-00474
• Device Sequence Number: 19177325
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: 04546540675880
• 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): 01/07/2019

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: 01/31/2021
• Device Catalogue Number: M0035423060
• Device Lot Number: 20270372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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)