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	05/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the coil delivery wire broken/fractured during use.There were no clinical consequences to the patient reported as a result of 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.Visual/microscopic inspection: the delivery wire was found to be broken/ fractured 11 cm from the proximal end.The delivery wire broke off completely during the analysis.The coil delivery wire was found to be kinked/bent.The main coil was found to be stretched as per photo.The suture was found to be intact.Functional inspection: main coil failed/unable to detach functional test: unable to perform the test as the delivery wire was found to be broken/fractured and broke off completely during analysis.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 not confirmed during device analysis however, the analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on functional and visual inspection.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging.The device was prepared for use as per the dfu and continuous flush was set up and maintained throughout the clinical procedure.It was reported that multiple attempts were made to detach the coil.The device was returned for analysis and the coil delivery wire was seen to be kinked and broken.The main coil was found stretched.The as analyzed codes 'coil delivery wire broken/fractured during use', 'coil delivery wire kinked/bent' and 'main coil stretched' will be assigned procedural factors 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.An assignable cause of 'not confirmed' was assigned to the aa reported defect 'main coil failed/unable to detach' 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.

• 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: 13442067
• Report Number: 3008881809-2022-00048
• Device Sequence Number: 19396044
• 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): 02/03/2022

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: 09/27/2023
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 22435067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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 MICROCATHETER (STRYKER); XT-17 MICROCATHETER (STRYKER)
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: Asian