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

Model Number	M0035433060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization procedure, it was reported that the physician thought the coil (subject device) was detached after hearing three beep sound from the power supply.However, when the physician was retracting the delivery wire, he observed that the coil came along with the delivery wire and was detached in the microcatheter.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
D4 expiration date: added.H4 manufacturing date: added.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 as well as a functional evaluation could not be performed.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.Based on the information currently available the exact cause for the reported event cannot be determined.
Event or Problem Description
During the coil embolization procedure, it was reported that the physician thought the coil (subject device) was detached after hearing three beep sound from the power supply.However, when the physician was retracting the delivery wire, he observed that the coil came along with the delivery wire and was detached in the microcatheter.No clinical consequences reprorted to the patient.
Additional Manufacturer Narrative
D3/h3 product available to stryker: updated d10 returned to manufacturer on: updated h3 device evaluated by mfg: updated h3 summary attached: updated the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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.During the analysis of the returned device, it was revealed that the main coil was electrolytically detached from the delivery wire and main coil was not returned.In addition, the coil proximal contact and delivery wire were found kinked due to handling damage.In the case of this complaint, it is most likely that the coil was only partially detached with the inzone and during withdrawal of the delivery wire in the microcatheter, premature detachment occurred.This event appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, a probable cause of procedural factors will be assigned to ¿main coil prematurely detached/separated during use'.
Event or Problem Description
During the coil embolization procedure, it was reported that the physician thought the coil (subject device) was detached after hearing three beep sound from the power supply.However, when the physician was retracting the delivery wire, he observed that the coil came along with the delivery wire and was detached in the microcatheter.No clinical consequences reported to the patient.

• Brand Name: TARGET HELICAL ULTRA 3 MM X 6 CM
• 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: 9335712
• Report Number: 3008881809-2019-00347
• Device Sequence Number: 11323732
• Product Code: HCG
• UDI-Device Identifier: 04546540676078
• UDI-Public: 04546540676078
• 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,Followup
• Report Date (Section B): 07/19/2020

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: 04/23/2022
• Device Model Number: M0035433060
• Device Catalogue Number: M0035433060
• Device Lot Number: 21383620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 10/26/2019
• Supplement Date Received by Manufacturer: 12/23/2019; 06/29/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/03/2020; 07/19/2020
• 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: SL-10 MICROCATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Age: 62 YR
• Patient Weight: 58