MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported that the subject coil could not be advanced through a microcatheter.There were no clinical consequences reported due to the event and the procedure was completed successfully.No further information is available.The subject coil device was returned for analysis, and it was discovered that the subject coil delivery wire was broken/fractured during use.There were no clinical consequences to the patient due to the event.
Additional Manufacturer Narrative
The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the subject coil device revealed that the subject coil delivery wire was noted to be kinked/bent and broken/fractured.Additionally, the main coil was seen to be stretched and kinked.A functional inspection was performed as the subject device was flushed but could not be advanced in the introducer sheath.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 subject coil was seen to be extremely damage during analysis.The subject coil delivery wire was kinked /bent and was broken/fractured.The main coil was also seen to be stretched and kinked/bent and friction was noted in the sheath.The as reported can be confirmed based on this as it can be presumed that friction was felt and then the damage noted was caused.The as reported ¿coil in catheter friction¿ as well as the as analyzed ¿main coil stretched, main coil kinked bent and coil introducer sheath friction¿ will be assigned 'procedural factors' as it 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.The as analyzed ¿coil delivery wire kinked bent¿ and ¿ coil delivery wire broken/fractured during use¿ will be assigned 'handling damage' as it appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• 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: 13957358
• Report Number: 3008881809-2022-00146
• Device Sequence Number: 20155333
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: 10/09/2024
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 23243528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: SL-10 PRE-SHAPED 90 MICROCATHETER (STRYKER)
• Patient Sex: Unknown