MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that the subject coil was prematurely detached inside the microcatheter during insertion into the aneurysm.Part of the coil was out of the microcatheter, and when the physician tried to pull back the delivery wire, the main coil could not be retracted back into the microcatheter.The physician ended the endovascular attempt and pulled all the devices together out of the patient¿s anatomy.On the back table, it was discovered that the coil had detached prematurely.The patient is doing fine and going to the surgery for clipping due to the anatomy not being amendable to endovascular treatment.
Event or Problem Description
It was reported that the subject coil was prematurely detached inside the microcatheter during insertion into the aneurysm.Part of the coil was out of the microcatheter, and when the physician tried to pull back the delivery wire, the main coil could not be retracted back into the microcatheter.The physician ended the endovascular attempt and pulled all the devices together out of the patient¿s anatomy.On the back table, it was discovered that the coil had detached prematurely.The patient is doing fine and going to the surgery for clipping due to the anatomy not being amendable to endovascular treatment.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was noted to be kinked.The coil was returned detached, stretched, and kinked/bent.There was dried blood/procedural fluid seen along the coil.Functional testing was not carried out as the coil was returned detached.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.Additional information provided by the customer indicated the device was prepared as per the dfu, the device was confirmed to be in good condition prior to use and continuous flush was maintained throughout the procedure.The device was returned, and it was confirmed that the coil had been prematurely detached and the damage noted to the device is indicative of the reported event.An assignable cause of procedural factors was assigned to the reported issues coil difficult to remove/withdraw from catheter and main coil prematurely detached/separated during use and to the analyzed issues coil delivery wire kinked/bent, main coil prematurely detached/separated during use, main coil stretched and main coil kinked/bent, as this issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12381307
• Report Number: 3008881809-2021-00350
• Device Sequence Number: 3848278
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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: 12/02/2023
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 22616807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 08/28/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY DUO MICROCATHETER (MICROVENTION)
• Patient Sex: Unknown