MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a total of 11 coils were used for collateral circulation embolism procedure.During procedure, the subject coil could not be advanced, and it was prematurely detached several centimeters from the hub due to the resistance in the microcatheter.The procedure was completed with other coils without adverse consequences to the patient.
Event or Problem Description
It was reported that a total of 11 coils were used for collateral circulation embolism procedure.During procedure, the subject coil could not be advanced, and it was prematurely detached several centimeters from the hub due to the resistance in the microcatheter.The procedure was completed with other coils without adverse consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned, therefore physical and functional tests could not be performed.Based on the information currently available, an assignable cause for this event cannot be determined.

• Brand Name: TARGET HELICAL ULTRA 2MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8680183
• Report Number: 3008881809-2019-00161
• Device Sequence Number: 13900197
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: 04546540676023
• 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): 07/11/2019

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: 11/04/2021
• Device Catalogue Number: M0035432080
• Device Lot Number: 20983413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: EXCELSIOR1018 MICROCATHETER (STRYKER); TAGET COILS (STRYKER); EXCELSIOR1018 MICROCATHETER (STRYKER); TAGET COILS (STRYKER)
• Patient Age: 6 MO