MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.
Event or Problem Description
It was reported that resistance was encountered when advancing the subject coil through the microcatheter and the coil was mechanically detached inside the microcatheter shaft.The broken part of the coil was removed by applying negative pressure with syringe.Another coil was used to complete the procedure successfully.No patient consequences reported due to this event.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device were not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the additional information provided by the customer indicated that there was no damage noted to the packaging and the device was prepared as per direction for use (dfu).While there are a number of potential causes for the reported issue, because the review and analysis of available information failed to identify a definitive cause, a cause of underminable was assigned to the as reported issue main coil prematurely detached/separated inside patient.
Event or Problem Description
It was reported that resistance was encountered when advancing the subject coil through the microcatheter and the coil was mechanically detached inside the microcatheter shaft.The broken part of the coil was removed by applying negative pressure with syringe.Another coil was used to complete the procedure successfully.No patient consequences reported due to this event.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8847302
• Report Number: 3008881809-2019-00222
• Device Sequence Number: 2824114
• Product Code: HCG
• UDI-Device Identifier: 04546540676016
• UDI-Public: 04546540676016
• Combination Product (Y/N): N
• 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): 08/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: M0035432060
• Device Lot Number: 20932426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention