MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
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 coil embolization for urgent gastrointestinal bleeding.After guiding the microcatheter to the target site, the coil (subject device) was selected as the first coil.After placing it, a short sound was heard three times.The detach button was pressed again and a long beep sounded, thus it was determined that the coil (subject device) was detached, and the delivery wire was removed.The microcatheter got deviated when the coil (subject device) came out and didn't detach.The coil (subject device) was retracted.The microcatheter was inserted again and this coil (subject device) was reused, nevertheless this coil was prematurely detached while advancement in the microcatheter shaft outside the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes (manufacturing execution system) 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer was when the detachment button was pressed on the detachment system a long beep sound was heard, so it was thought that the coil had detached, so therefore the delivery wire was removed, however, the coil had in fact not detached correctly, the coil was retracted once and reinserted back into the microcatheter, but coil was prematurely detached during advancement in the microcatheter.It was reported that the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, but it was reported that that continuous flush was not set up and maintained during the procedure and as per the dfu this is a required step to prepare and maintain flush throughout clinical procedure so therefore its probable this was the cause of the reported event occurring.So therefore, a probable cause of user error will be assigned to the reported codes since there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.
Event or Problem Description
It was reported that during coil embolization for urgent gastrointestinal bleeding.After guiding the microcatheter to the target site, the coil (subject device) was selected as the first coil.After placing it, a short sound was heard three times.The detach button was pressed again and a long beep sounded, thus it was determined that the coil (subject device) was detached, and the delivery wire was removed.The microcatheter got deviated when the coil (subject device) came out and didn't detach.The coil (subject device) was retracted.The microcatheter was inserted again and this coil (subject device) was reused, nevertheless this coil was prematurely detached while advancement in the microcatheter shaft outside the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 3MM X 4CM
• 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: 14379942
• Report Number: 3008881809-2022-00222
• Device Sequence Number: 5150127
• Product Code: HCG
• UDI-Device Identifier: 07613252600336
• UDI-Public: 07613252600336
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 10/19/2024
• Device Model Number: M0035443040
• Device Catalogue Number: M0035443040
• Device Lot Number: 23248648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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: 1.9FR CARNELIAN MARVEL (TOKAI MEDICAL).; INZONE (STRYKER).
• Patient Sex: Unknown