MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036125100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿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.During analysis, the subject main coil was inserted inside the microcatheter when received and the coil delivery wire was noted to be kinked/bent.The subject main coil could not be advanced through the microcatheter.During an attempt to retrieve the subject coil proximally, it felt like the subject main coil was stretched inside the microcatheter and broke at the coil junction.However, as the physician reported that the subject coil deployed inside the microcatheter it will be concluded that the coil deployed due to a break to the main coil.The microcatheter was cut to try to retrieve the subject main coil but the microcatheter contained significant amounts of dried blood and the coil could not be retrieved without causing significant damage to the coil.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 events were confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.It was reported that there was friction in the coil introducer sheath and that the subject main coil then got jammed and deployed in the microcatheter.It is likely that the subject main coil was damaged when advanced against resistance which may have resulted in damage to the microcatheter inner lumen and subsequent jamming of the subject coil within the microcatheter.An assignable cause of procedural factors will be assigned to the as reported, coil introducer sheath friction, coil jammed, main coil prematurely detached/separated during use and the as analysed main coil broken/fractured during use and coil jammed.This complaint 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the as analysed coil delivery wire kinked/bent as 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 when the subject coil was advancing inside the catheter shaft it got stuck and deployed prematurely.The catheter was removed and replaced causing a surgical delay of 10 minutes.The procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure when the subject coil was advancing inside the catheter shaft it got stuck and deployed prematurely.The catheter was removed and replaced causing a surgical delay of 10 minutes.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 10CM
• 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: 19446224
• Report Number: 3008881809-2024-00244
• Device Sequence Number: 19649350
• Product Code: HCG
• UDI-Device Identifier: 07613327128314
• UDI-Public: 07613327128314
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/26/2024

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: 11/27/2025
• Device Catalogue Number: M0036125100
• Device Lot Number: 24040148
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown