MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036102050
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the physician encountered difficulty advancing the subject coil within the microcatheter and required force to push.Once the subject coil was visible the delivery wire of the subject coil was pulled back but the subject coil had detached prematurely in the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.D4 lot # - updated.D4 gtin - updated.D9 returned to manufacturer on - updated.D9 product available to stryker ¿ updated.G4 pma/510(k) - updated.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed with the packaging returned with the device.During visual inspection, the device was inside the microcatheter when received.The coil delivery wire was seen to be kinked/bent.The delivery wire was seen to be broken at the detachment zone.The main coil was seen to be stretched.The coil introducer sheath was not returned.During functional inspection, the main coil could not be advanced through the microcatheter.Upon retracting the delivery wire, it was noted that the coil remained inside.The microcatheter was cut, and the coil was successfully retrieved.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Per the event description the main coil was advanced against resistance through the microcatheter.Per the device analysis the pi (polyimide) wire was found to be physically broken and this is likely to have happened due to the pulling/pushing the device against resistance.An assignable cause of procedural factors will be assigned to the as reported events of main coil prematurely detached/separated during use and coil in catheter friction and to the as analyzed events of main coil prematurely detached/separated during use, main coil stretched and coil jammed.The issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of handling damage will be assigned to the as analyzed event of coil delivery wire kinked/bent.The issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during the procedure, the physician encountered difficulty advancing the subject coil within the microcatheter and required force to push.Once the subject coil was visible the delivery wire of the subject coil was pulled back but the subject coil had detached prematurely in the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 20MM X 50CM
• 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: 20110379
• Report Number: 3008881809-2024-00393
• Device Sequence Number: 12699811
• Product Code: HCG
• UDI-Device Identifier: 07613327004731
• UDI-Public: (01)07613327004731(17)260808(10)24451110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123377
• 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): 10/14/2024

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: 08/08/2026
• Device Catalogue Number: M0036102050
• Device Lot Number: 24451110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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 MICROCATHETER (STRYKER)
• Patient Sex: Unknown