MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452560
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During clinical coiling procedure for an aneurysm located at the middle cerebral artery (mca), the aneurysm was framed with 2-trenza devices (8mm /6mm) and 4-target coils were deployed.It was reported that the next target coil (subject device) encountered resistance in the introducer sheath and between coil delivery system.The subject coil was able to pull back and it would not advance forward.The coil (subject device) was partially detached inside the microcatheter.The physician pulled back catheter and was attempted again after repositioning the microcatheter and could not push the coil (subject device) out the second time.Since a total of 4 target coils already deployed, the physician decided not putting in any more coils.The procedure was successfully completed without clinical consequences to the patient.
Event or Problem Description
During clinical coiling procedure for an aneurysm located at the middle cerebral artery (mca), the aneurysm was framed with 2-trenza devices (8mm /6mm) and 4-target coils were deployed.It was reported that the next target coil (subject device) encountered resistance in the introducer sheath and between coil delivery system.The subject coil was able to pull back and it would not advance forward.The coil (subject device) was partially detached inside the microcatheter.The physician pulled back catheter and was attempted again after repositioning the microcatheter and could not push the coil (subject device) out the second time.Since a total of 4 target coils already deployed, the physician decided not putting in any more coils.The procedure was successfully completed without clinical consequences to the patient.
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.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.H3 other text: the subject device is unavailable to manufacturer.

• Brand Name: TARGET HELICAL NANO 2.5MM X 6CM
• 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: 11951174
• Report Number: 3008881809-2021-00225
• Device Sequence Number: 19894382
• Product Code: HCG
• UDI-Device Identifier: 07613252600411
• UDI-Public: 07613252600411
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/07/2021

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: 10/19/2023
• Device Model Number: M0035452560
• Device Catalogue Number: M0035452560
• Device Lot Number: 22526043
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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: CITADEL DEVICE (STRYKER); EXCELSIOR 1018 STRAIGHT MICROCATHETER (STRYKER); INFINITY CATHETER (STRYKER); TARGET COILS (STRYKER); TRENZA DEVICES (STRYKER); VECTA 74 (STRYKER)
• Patient Age: 50 YR