MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the coil embolization procedure, friction was observed in the catheter lumen and when physician tried to pull out the subject coil, it detached unintentionally in the microcatheter.The detached coil could not be located under fluoroscopy.There were no clinical consequences reported to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device was not returned for the analysis and the reported defect could not be confirmed.In the case of this complaint it is most likely that the coil got stuck inside a microcatheter during device insertion and excessive force was used in order to remove it.The coil then physically detached from the delivery wire as a result.The microcatheter used with this coil was inspected and the lumen of the catheter was found blocked by crystalized saline.It is therefore possible that the coil got jammed.This however cannot be conclusively determined as no coil was found inside the microcatheter.Based on the investigation results and available information, an assignable cause of undeterminable will be assigned to the main coil prematurely detached/separated inside patient as the device was not returned and review and analysis of all available information failed to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during the coil embolization procedure, friction was observed in the catheter lumen and when physician tried to pull out the subject coil, it detached unintentionally in the microcatheter.The detached coil could not be located under fluoroscopy.There were no clinical consequences reported to the patient.

• Brand Name: TARGET HELICAL NANO 1MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8097271
• Report Number: 3008881809-2018-00498
• Device Sequence Number: 1988108
• Product Code: HCG
• UDI-Device Identifier: 04546540698001
• UDI-Public: 04546540698001
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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: 03/07/2021
• Device Catalogue Number: M0035431020
• Device Lot Number: 20372626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/21/2018
• 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)