MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
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 the ica aneurysm procedure the physician was unable to advance the coil(subject device) through a microcatheter, the resistance caused the proximal end of coil(subject device) delivery wire to break inside microcatheter.The coil was then completely removed.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the main coil was seen to be kinked/bent and stretched.The coil delivery wire was seen to be kinked/bent.The coil delivery wire was seen to be broken/fractured.The coil introducer sheath was intact.Functional inspection: when the coil was moved through the received introducer sheath, there was a lot of resistance, so the coil had to be pulled back through the proximal end of the introducer.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that continuous flush set up and maintained throughout the procedure.No damage was noted to the 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.The physician was unable to advance the coil through the microcatheter; the resistance caused the delivery wire to break.It is noted that the coil was "advanced with a little more force than normal but not excessive".During analysis, the main coil was seen to be kinked/bent, the coil delivery wire was seen to be kinked/bent and the coil delivery wire was seen to be broken/fractured.An attempt was made to do a functional inspection, the coil was moved through the received introducer sheath, there was a lot of resistance, so the coil had to be pulled back through the proximal end of the introducer.An assignable cause of handling damage will be assigned to the as reported/as analysed 'coil delivery wire broken/fractured during use' and the as analysed 'coil delivery wire kinked/bent', as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.An assignable cause of procedural factors was assigned to the as reported/ as analysed 'coil in catheter friction' as well as the as analysed defects 'main coil kinked/bent' and 'main coil stretched' as this complaint appears 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 factors during use.
Event or Problem Description
It was reported that during the ica aneurysm procedure the physician was unable to advance the coil(subject device) through a microcatheter, the resistance caused the proximal end of coil(subject device) delivery wire to break inside microcatheter.The coil was then completely removed.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• 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: 15422524
• Report Number: 3008881809-2022-00451
• Device Sequence Number: 14149532
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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: 09/10/2022
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 21710791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• 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: BENCHMARK GUIDE CATHETER(NON-STRYKER); PLATO MICROCATHETER(NON-STRYKER)
• Patient Sex: Unknown