MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036124080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the coil embolization procedure for treating carotid-cavernous fistula, resistance was encountered within the microcatheter.When the subject coil was retrieved, it prematurely detached within the microcatheter.The subject coil along with the microcatheter was removed out of the patient¿s body and subject device was replaced.The procedure was completed successfully with the same microcatheter with no clinical consequences to the patient.
Event or Problem Description
During the coil embolization procedure for treating carotid-cavernous fistula, resistance was encountered within the microcatheter.When the subject coil was retrieved, it prematurely detached within the microcatheter.The subject coil along with the microcatheter was removed out of the patient¿s body and subject device was replaced.The procedure was completed successfully with the same microcatheter with no clinical consequences to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The device was analyzed and the coil delivery wire was noted to be kinked/bent , the main coil was detached and the proximal contact wire was broken/fractured.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.Based on the event description, it was stated that the coil had detached in the microcatheter, as the coil and microcatheter were not returned, we can confirm this base on the event description and assign procedural factors.An assignable cause of procedural factors will be assigned to the as reported "main coil prematurely detached/separated during use' and 'coil in catheter friction' as these defects 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 the event description, the anatomy was normal and the device was set up according to the directions, therefore, an assignable cause of 'handling damage' will be assigned to the as analyzed, 'coil delivery wire kinked/bent' and 'coil proximal contact wire broken/fractured' as the issue is due to handling of the product or portion of the product during the clinical procedure.During visual/microscopic inspection the coil delivery wire was seen to be kinked/bent.The main coil was found to be detached/separated.The coil proximal contact wire was seen to be broken/fractured.Functional inspection could not be performed, as the main coil prematurely detached/separated during use and only the delivery wire was returned.The as analyzed defects 'coil delivery wire kinked/bent', 'main coil prematurely detached/ separated during use' and 'coil proximal contact wire broken/fractured' will be assigned to this investigation.

• Brand Name: TARGET XL 360 SOFT 4MM X 8CM
• 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: 16768268
• Report Number: 3008881809-2023-00192
• Device Sequence Number: 6386936
• Product Code: HCG
• UDI-Device Identifier: 07613327128390
• UDI-Public: 07613327128390
• 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): 05/18/2023

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: 11/25/2025
• Device Model Number: M0036124080
• Device Catalogue Number: M0036124080
• Device Lot Number: 24040090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2022
• 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: UNKNOWN MICROCATHETER
• Patient Sex: Unknown