MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452060
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after inserting the subject coil into the microcatheter and detaching it, the delivery wire was pushed out a little inside the microcatheter and then removed.When an attempt was made to retrieve the microcatheter, the subject detached coil was attached to the tip of the microcatheter, thus this subject detached coil was retrieved with the entire microcatheter to the outside of the body.The entire subject coil was safely removed with the microcatheter, and the procedure was completed as it was (no additional coil to place).There were no clinical consequences reported due to the event.
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.It was reported that after inserting the subject coil of lot # 22590357 into sl-10 45° microcatheter and detaching it, the delivery wire was pushed out a little inside sl-10 microcatheter and then removed.When an attempt was made to retrieve the sl-10 microcatheter, the subject detached coil was attached to the tip of the sl-10 microcatheter, thus this subject detached coil was retrieved with the entire sl-10 microcatheter to the outside of the body.It is probable that the subject detached coil was subsequently stuck/entangled on the distal end of the sl-10 microcatheter causing its removal during removal of the microcatheter.An assignable cause of caused by other will be assigned to the reported ¿device interaction with another device¿ and ¿ main coil migration¿, as the investigation indicates another product/drug/subsequent procedure caused the issue event.

• Brand Name: TARGET HELICAL NANO 2MM X 6CM
• 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: 13839353
• Report Number: 3008881809-2022-00129
• Device Sequence Number: 19080239
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: 07613252600381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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: 11/16/2023
• Device Model Number: M0035452060
• Device Catalogue Number: M0035452060
• Device Lot Number: 22590357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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)
• Patient Sex: Unknown