MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036126200
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis, and it was discovered that the coil (subject device) found to have prematurely detached or separated.A portion of the coil that was removed from the microcatheter was found to be fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 main coil was noted to be stuck inside of the microcatheter.The coil delivery wire was noted to be kinked/bent.The main coil was noted to be detached/separated.The portion of the coil was removed from the microcatheter and noted to be stretched and broken/fractured.A functional inspection could not be carried out due to the damage noted.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 'coil in catheter friction', 'main coil friction' and 'main coil difficulty inserting' could not be duplicated during device analysis; however, the analysis results are consistent with the reported event.It was reported that the physician tried inserting the subject coil, which also got stuck in the microcatheter and was unable to be retracted.Additional information provided by the customer indicated that device prepared as per the dfu and continuous flush was maintained for the duration of the procedure.The device was returned for analysis, and it was noted that the main coil was stuck inside the microcatheter.Additionally, the coil delivery wire was found to be kinked or bent.The main coil was also found to have prematurely detached or separated.Finally, a portion of the coil that was removed from the microcatheter was found to be stretched and fractured.Based on a review of all available information and the analysis of the returned device it is probable that procedural factors contributed to the as analyzed 'coil jammed', 'main coil stretched', 'main coil broken/fractured during use', 'main coil prematurely detached/separated during use', and 'coil delivery wire kinked/bent.' this complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the reported complaint.

• Brand Name: TARGET XL 360 SOFT 6MM 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: 20251827
• Report Number: 3008881809-2024-00429
• Device Sequence Number: 8755122
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 07/03/2026
• Device Catalogue Number: M0036126200
• Device Lot Number: 24408043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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: SL- 10 CATHETER (STRYKER)
• Patient Sex: Unknown