MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure the coil (subject device) didn't detach originally even after seven attempts using an inzone detachment system, but finally the coil (subject device) detached inside the catheter.The anatomical location were the issue occurred was acom ¿anterior communicating artery¿.The physician replaced it with a new coil and continued the procedure without any clinical consequences to the patient.
Event or Problem Description
It was reported that during procedure the coil (subject device) didn't detach originally even after seven attempts using an inzone detachment system, but finally the coil (subject device) detached inside the catheter.The anatomical location were the issue occurred was acom ¿anterior communicating artery¿.The physician replaced it with a new coil and continued the procedure without any clinical consequences to the patient.
Additional Manufacturer Narrative
Catalog number/lot number - updated.Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.
Event or Problem Description
It was reported that during procedure the coil (subject device) didn't detach originally even after seven attempts using an inzone detachment system, but finally the coil (subject device) detached inside the catheter.The anatomical location were the issue occurred was acom ¿anterior communicating artery¿.The physician replaced it with a new coil and continued the procedure without any clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be kinked/bent, the coil delivery wire was found to be broken/fractured, the main coil was found to be stretched, the suture was found to be intact, and the main coil was found to be attached.A functional test was unable to perform as the coil delivery wire was found to be broken/fractured.The reported complaint was not confirmed during device analysis.The device failed to meet specifications when received for complaint investigation based on damage noted to the device during the 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.Additional information provided by the customer indicated that the device prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis and the coil delivery wire was noted to be kinked/bent and was broken.The main coil was returned attached and could not be detached during analysis due to the broken delivery wire.The main coil was stretched.It is probable that the delivery wire was kinked and broken as a result of handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the reported ¿main coil failed/unable to detach¿ and the analyzed ¿coil delivery wire kinked/ bent¿ and 'coil delivery wire broken/fractured during use¿.The as reported ¿main coil detached prematurely during use¿ was not confirmed during analysis as the coil was returned attached, therefore ¿main coil detached prematurely during use¿ will be assigned not confirmed.The as analyzed 'main coil stretched¿ will be assigned procedural factors as this 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.

• Brand Name: TARGET 360 ULTRA 5MM X 10CM
• 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: 12637202
• Report Number: 3008881809-2021-00437
• Device Sequence Number: 19133816
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

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: 09/27/2023
• Device Model Number: M0036125150
• Device Catalogue Number: M0035425100
• Device Lot Number: 22458311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 01/26/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 12/09/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• 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: INZONE (STRYKER MANUFACTURER).; SL-10 CATHETER (STRYKER MANUFACTURER).
• Patient Sex: Unknown