MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
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.Visual inspection of the subject device coil revealed that the coil delivery wire was kinked as the result of handling of the product during use.Additionally, the suture was damaged, the main coil was kinked, stretched and broken.Functional testing was not performed as the coil was severely damaged.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.Information provided by the customer indicated that the subject device coil was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the procedure, and no resistance was encountered when advancing the subject coil through the introducer sheath.In the case of this complaint, it is most likely that the main coil did not fully detach during the case and was damaged (kinked, stretched, broke) upon retraction in the microcatheter.An assignable cause of procedural factors will be assigned to this investigation since these issues 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 and/or anatomical factors during use.
Event or Problem Description
Analysis of the returned device revealed that the subject coil was broken.There were no clinical consequences reported to the patient.

• Brand Name: TARGET HELICAL NANO 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10394409
• Report Number: 3008881809-2020-00238
• Device Sequence Number: 16881147
• Product Code: HCG
• UDI-Device Identifier: 07613252600374
• UDI-Public: 07613252600374
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 08/11/2020

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: 02/02/2022
• Device Model Number: M0035452040
• Device Catalogue Number: M0035452040
• Device Lot Number: 21198454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/11/2020
• 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: SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 66 YR