MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a a-com embolization with the subject coil, it became stuck in catheter.When it was removed, the coil was found prematurely detached.The patients medical condition was good.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.A visual microscope inspection was performed and found the main coil was detached manually, the proximal contact wire was intact and the coil delivery wire slightly kinked/bent.The distal tip was found to be intact and the main coil was kinked/bent.A functional test was unable to carry out due to the condition of the returned device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event was confirmed.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported issue.
Event or Problem Description
It was reported that during a a-com embolization with the subject coil, it became stuck in catheter.When it was removed, the coil was found prematurely detached.The patients medical condition was good.There were no clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9745346
• Report Number: 3008881809-2020-00051
• Device Sequence Number: 2456196
• Product Code: HCG
• UDI-Device Identifier: 07613252600374
• UDI-Public: 07613252600374
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 04/21/2020

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: 12/09/2021
• Device Model Number: M0035452040
• Device Catalogue Number: M0035452040
• Device Lot Number: 21072805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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 (STRYKER); EXCELSIOR SL-10 (STRYKER)