MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5 MM X 10 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475100
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned.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.It was reported that during the procedure, the middle part of the subject coil became invisible under fluoroscopy.The surgeon stated that there was possibility that the hub was overtightened when the coil was inserted, and the middle part of the coil was stretched.Additional information provided by the customer indicated that there was no allegation against associated devices used in the procedure, no damage was noted to the device packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was very tortuous, and no excessive force was applied while advancing the coil.In the case of this complaint, it is possible that overtightening of the rhv may have caused damage to the middle part of the coil when advancing it through and as a result the coil was not fully visible under fluoroscopy.The patient's tortuous anatomy may have also contributed to difficulties encountered during the procedure that may have resulted in the coil stretching.An assignable cause of procedural factors will be assigned to this complaint since these issues appear to be associated with a product that met stryker 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.
Event or Problem Description
It was reported that during the procedure the middle part of the subject coil became invisible under fluoroscopy and physician stated that the physician might have overtightened the hub when the subject coil was inserted into the micro catheter and the coil got stretched.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 5 MM X 10 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11396334
• Report Number: 3008881809-2021-00106
• Device Sequence Number: 13773817
• Product Code: HCG
• UDI-Device Identifier: 04546540676498
• UDI-Public: 04546540676498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/01/2021

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: 08/30/2023
• Device Model Number: M0035475100
• Device Catalogue Number: M0035475100
• Device Lot Number: 22421500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR