MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
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 during visual inspection, the introducer sheath was found kinked.The proximal contact was seen to be completely detached.The coil delivery wire was found broken and the main coil was seen to be stretched.During the functional testing , the device was flushed but would not advance in the introducer sheath and had to be retracted from the 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 device was returned for analysis and the proximal contact was noted to be completely detached, introducer sheath and coil delivery wire was seen to be kinked, the coil delivery wire was also seen to be broken and the main coil was stretched.It is probable that the damage noted was sustained due to handling of the device during the clinical procedure therefore an assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire broken/fractured during use' and to the as analyzed 'coil delivery wire kinked/ bent'.An assignable cause of 'not confirmed' was assigned to the as reported defect 'coil proximal contact wire broken/fractured' ¿as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The as analyzed 'coil introducer sheath kinked/bent', 'coil proximal contact detached/separated', 'main coil stretched' and 'coil introducer sheath friction' will be assigned procedural factors as these defects 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 or anatomical factors during use.
Event or Problem Description
Analysis of the returned device found that the subject coil delivery wire broken/ fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• 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: 12920523
• Report Number: 3008881809-2021-00506
• Device Sequence Number: 4994615
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• 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
• Report Date (Section B): 12/02/2021

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: 02/14/2024
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 22737108
• 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): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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: INZONE DETACHMENT SYSTEM (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: Asian