MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036128300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the returned device revealed that the proximal contact wire was detached/separated, the main coil was severely stretched/tangled and the suture was broken.Additionally, the main coil was broken.Procedural fluids were noted on the stretched/damaged main coil.A functional test could not be performed as the visual defect was confirmed 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 device was returned and the damage noted to the device is indicative of friction during use.It is probable that the device was damaged during advancement or withdrawal within the microcatheter due to anatomical factors.An assignable cause of procedural factors will be assigned to the reported ¿ main coil stretched, and the analysed defects, ¿coil proximal contact detached/separated¿, ¿main coil stretched', ¿main coil tangled, 'main coil suture damage' and 'main coil broken/fractured during use, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was initially reported that the coil (subject device) was stretched during use.Analysis of the returned main coil (subject device) was found to be broken during use.There was no clinical consequence to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 8MM 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: 11833111
• Report Number: 3008881809-2021-00209
• Device Sequence Number: 13664415
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/17/2021

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: 10/19/2022
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 21845646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/17/2021
• 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: MICROCATHETER (UN KNOWN MANUFACTURER)