MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180630
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not yet returned.
Event or Problem Description
It was reported that during the procedure, a coil was stuck at the hub of the microcatheter and was replaced with the subject coil.Friction was reported when moving the subject coil inside the introducer sheath and inside the microcatheter.It was reported that the subject coil was stuck in the shaft; and upon retrieval, the subject coil prematurely detached inside the microcatheter.The physician withdrew the whole system.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, a coil was stuck at the hub of the microcatheter and was replaced with the subject coil.Friction was reported when moving the subject coil inside the introducer sheath and inside the microcatheter.It was reported that the subject coil was stuck in the shaft; and upon retrieval, the subject coil prematurely detached inside the microcatheter.The physician withdrew the whole system.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date added.H3 device evaluated by mfg updated.H3 summary attached updated.D4 expiration date added.D10/h3 product available to stryker updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the introducer sheath was found to be damaged.The tip of the introducer sheath was found to be damaged.The main coil was found to be broken/fractured and stuck inside the microcatheter.The main coil was found to be stretched.The suture was found to be broken.Functional inspection could not be performed due to the damaged condition of the returned subject coil.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 there was friction or resistance while the coil was advancing the introducer sheath, there was no resistance when the coil was taken out of dispenser hoop, the rhv was adequately tightened while the introducer sheath was in the hub (not over/under-tightened), but continuous flush was not set up and maintained throughout the clinical procedure.The device was returned for analysis and the introducer sheath was found to be damaged, the main coil was found to be broken/fractured and also stretched.The as analyzed codes 'coil introducer sheath damaged', '¿main coil broken/fractured during use', ¿ main coil stretched', ¿ main coil suture damage', and ¿ catheter, coil jammed' 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.Based on analysis, an assignable cause of handling damage will be assigned to the as reported (ar) ¿ coil in catheter friction' since these issues were associated with handling of the device during the clinical procedure.An assignable cause of 'not confirmed' was assigned to the ar defect ¿ main coil prematurely detached/separated during use', and ¿ coil introducer sheath friction' 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 XXL 360 6MM X 30CM
• 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: 12879982
• Report Number: 3008881809-2021-00494
• Device Sequence Number: 4950141
• Product Code: HCG
• UDI-Device Identifier: 07613327466393
• UDI-Public: 07613327466393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 03/10/2022

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: 06/08/2023
• Device Model Number: M0036180630
• Device Catalogue Number: M0036180630
• Device Lot Number: 22048762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 11/28/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2020
• 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: EXCELSIOR 1018 MICROCATHETER (STRYKER).; TARGET COIL (STRYKER).
• Patient Sex: Unknown