MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036124120
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject coil could not be detached and when withdrawn, the subject coil prematurely detached inside the microcatheter.No clinical consequences were reported to the patient due to this event.No further information is available.
Event or Problem Description
It was reported that during the procedure the subject coil could not be detached and when withdrawn, the subject coil prematurely detached inside the microcatheter.No clinical consequences were reported to the patient due to this event.No further information is available.
Additional Manufacturer Narrative
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 visual inspection the main coil was seen to be detached/separated from delivery wire.The main coil was seen to be kinked/bent and stretched.The coil delivery wire was seen to be kinked/bent.The coil introducer sheath was intact.During functional inspection the main coil was seen to be stuck inside of a catheter, later the catheter was flushed and coil was removed.The functional inspection was not carried out due to the damage noted to the device.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 'main coil prematurely detached/separated during use was confirmed during the analysis.The ¿main coil failed unable to detach¿ could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on damage noted to the device during the analysis.The device failed to meet specifications when received for complaint investigation based on damage noted to the device during the analysis.Additional information provided by the customer indicated that despite several attempts, the coil would not detach.Eventually, it had to be withdrawn, but accidentally detached inside the microcatheter.The device was analysed and the main coil was seen to be kinked/bent, stretched and detached/separated from delivery wire the coil delivery wire was noted to be kinked/bent.An assignable cause of procedural factors will be assigned to the reported defects ¿main coil prematurely detached/separated during use¿ and ¿main coil failed unable to detach¿ and to the analysed defects ¿main coil kinked/bent¿, ¿main coil stretched¿ and ¿main coil prematurely detached/separated during use¿.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.An assignable cause of handling damage will be assigned to the analysed defect ¿coil delivery wire kinked/bent¿ as the issue is due to handling of the product or portion of the product during the clinical procedure.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 17214986
• Report Number: 3008881809-2023-00319
• Device Sequence Number: 16896820
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: 07613327128338
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 08/24/2023

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: 09/17/2025
• Device Model Number: M0036124120
• Device Catalogue Number: M0036124120
• Device Lot Number: 23902449
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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: HEADWAY DUO CATHETER(MICROVENTION).
• Patient Sex: Unknown