MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the subject coil was prematurely detached during filling in the mass.There were no clinical consequences to the patient due to the reported event.No other information was provided.
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, the subject coil was prematurely detached during filling in the mass.There were no clinical consequences to the patient due to the reported event.No other information was provided.
Additional Manufacturer Narrative
D4 expiration date - added.D9/h3 product available to stryker ¿ updated.D9 returned to manufacturer on - updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the returned device found that the subject coil was found to be broken, kinked and stretched.Additionally, the coil delivery wire was seen to be kinked/bent.A functional testing could not be performed due to the condition of the returned device.The reported ¿main coil prematurely dethatched/separated during use¿ was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies 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.Addition information received was the device was prepared 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 prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The device was returned, and the subject coil was found to be still attached to the delivery wire not confirming the reported event, the coil was found to be broken, kinked and stretched.The delivery wire was returned and found to be kinked/bent.The introducer sheath was not returned.In the case of this complaint it is most likely that when the device encountered difficulties during the clinical procedure, the damage caused to the delivery wire and main coil was due to handling and manipulation of the device.The analyzed code ¿main coil broken/fractured during use¿, ¿main coil stretched¿ and ¿main coil kinked/bent¿ will be assigned procedural factors as 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 factors during use.An assignable cause of handling damage will be assigned to the analyzed codes ¿coil delivery wire kinked/bent¿ as the issue is associated with handling of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.An assignable cause of 'not confirmed' will be assigned to the reported code ¿main coil prematurely dethatched/separated during use¿ as the coil was found to be still attached during device analysis.(note: this is 1 of 2 reports).

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• 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: 15189005
• Report Number: 3008881809-2022-00389
• Device Sequence Number: 5977240
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• 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): 10/24/2022

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: 02/19/2025
• Device Model Number: M0036121040
• Device Catalogue Number: M0036121040
• Device Lot Number: 23491163
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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: MICROCATHETER (UNKNOWN MANUFACTURER).
• Patient Sex: Unknown