MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
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 the procedure at pulmonary artery, the coil (subject device) may have become entangled when inserting and removing it, and the coil (subject device) was prematurely detached inside the microcatheter when it was retracted.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.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 at pulmonary artery, the coil (subject device) may have become entangled when inserting and removing it, and the coil (subject device) was prematurely detached inside the microcatheter when it was retracted.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.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 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 while the coil was been advanced within the microcatheter the coil became detached prematurely inside the catheter, according to further information the coil may have also become tangled inside the catheter.It was reported that the device was prepared as per the dfu (device directions for use), 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 (device directions for use) 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 (device directions for use) that resulted in a different medical product response than intended by the manufacturer or expected by the user.

• Brand Name: TARGET XXL 360 5MM X 20CM
• 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: 13884155
• Report Number: 3008881809-2022-00138
• Device Sequence Number: 20157680
• Product Code: HCG
• UDI-Device Identifier: 07613327466379
• UDI-Public: 07613327466379
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: 08/07/2024
• Device Model Number: M0036180520
• Device Catalogue Number: M0036180520
• Device Lot Number: 23082654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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
• Patient Sex: Unknown