MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035477300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2021
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 fractured when advanced through the microcatheter shaft.The coil and microcatheter were replaced, and the procedure was completed successfully.No patient consequences were reported due to this event.
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 delivery wire was noted to be kinked/bent at the proximal end and the proximal contact was found to be broken/fractured.Dried blood was noted on the delivery wire at the proximal end of the introducer sheath, and flushing the sheath freed the sheath from the delivery wire.During functional testing, the main coil was able to advance through the introducer sheath without friction and the main coil was noted to be intact.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 that 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 coil was not advanced or retracted with force, the patient's anatomy was not tortuous, and all broken parts of the coil were able to remove from the patient's anatomy.There was no allegation against the microcatheter (sl-10) used in the procedure.During analysis, the coil delivery wire was found to be kinked/bent at the proximal end and the proximal contact wire was broken/fractured.The main coil was found to be intact when advanced through the introducer sheath with no visible damage noted.Therefore, the as reported issue main coil broken/fractured during use was not confirmed.In the case of this complaint, it is probable that the fractured proximal contact was interpreted as damage to the main coil.It is probable that the damage to the delivery wire and proximal contact were sustained due to handling of the device during delivery in the microcatheter.Therefore, an assignable cause of handling damage will be assigned to the as analyzed issues coil delivery wire kinked/bent and coil proximal contact wire broken/fractured.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that the subject coil was fractured when advanced through the microcatheter shaft.The coil and microcatheter were replaced, and the procedure was completed successfully.No patient consequences were reported due to this event.

• Brand Name: TARGET 360 SOFT 7MM X 30CM
• 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: 11559280
• Report Number: 3008881809-2021-00136
• Device Sequence Number: 14647793
• Product Code: HCG
• UDI-Device Identifier: 04546540676580
• UDI-Public: 04546540676580
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/08/2021

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: 01/29/2022
• Device Model Number: M0035477300
• Device Catalogue Number: M0035477300
• Device Lot Number: 21176145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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)
• Patient Age: 71 YR