MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035475200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a neurovascular procedure, the operator positioned the microcatheter in the aneurysm, there after the operator transferred the subject coil into the microcatheter and deployed the subject coil inside the aneurysm.Suddenly the operator felt resistance when continuing to advance it.The operator decided to remove the subject coil, when doing so the operator felt that the subject coil was not coming out completely.The operator saw that the subject coil had been cut (without having released it) in a portion, leaving a piece of subject coil inside the microcatheter.It was reported that the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer , the device was prepared for use as per the dfu.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.Continuous flush was set up and maintained throughout the clinical procedure.The doctor positioned the microcatheter in the aneurysm, deployed the coil, and felt resistance while advancing.Upon removing the coil, they discovered it was broken, leaving a piece inside the microcatheter.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned.
Event or Problem Description
It was reported that during a neurovascular procedure, the operator positioned the microcatheter in the aneurysm, there after the operator transferred the subject coil into the microcatheter and deployed the subject coil inside the aneurysm.Suddenly the operator felt resistance when continuing to advance it.The operator decided to remove the subject coil, when doing so the operator felt that the subject coil was not coming out completely.The operator saw that the subject coil had been cut (without having released it) in a portion, leaving a piece of subject coil inside the microcatheter.It was reported that the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during a neurovascular procedure, the operator positioned the microcatheter in the aneurysm, there after the operator transferred the subject coil into the microcatheter and deployed the subject coil inside the aneurysm.Suddenly the operator felt resistance when continuing to advance it.The operator decided to remove the subject coil, when doing so the operator felt that the subject coil was not coming out completely.The operator saw that the subject coil had been cut (without having released it) in a portion, leaving a piece of subject coil inside the microcatheter.It was reported that the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H6 type of investigation - method code grid - updated.H6 investigation findings - results code grid - updated.H6 investigation conclusions - conclusion code grid - updated.Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject coil was returned for analysis.On visual/microscopic inspection the coil delivery wire was noted to be kinked.The main coil was seen to be severely stretched and kinked.The main coil was seen to be broken.The coil introducer sheath was not returned.Functional inspection: unable to perform due to condition of 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 reported event was confirmed based on the device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer , the device was prepared for use as per the dfu.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.Continuous flush was set up and maintained throughout the clinical procedure.The doctor positioned the microcatheter in the aneurysm, deployed the coil, and felt resistance while advancing.Upon removing the coil, they discovered it was broken, leaving a piece inside the microcatheter.During analysis, the coil delivery wire was noted to be kinked, the main coil was broken, stretched and kinked.Based on a review of the available information and analysis of the returned device, it is probable that there may have been procedural/anatomical factors present, causing the reported friction during advancement of the device which led to the subsequent device fracture and damage.An assignable cause of procedural factors will be assigned to the as reported main coil broken/fractured during use and coil in catheter friction, 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 procedural factors will be assigned to the as analyzed main coil broken/fractured during use, main coil stretched and main kinked/bent¿ 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 as analyzed coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during preparation.

• Brand Name: TARGET 360 SOFT 5MM 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: 17954126
• Report Number: 3008881809-2023-00511
• Device Sequence Number: 6790875
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: 04546540676511
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 02/13/2024

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: 07/31/2025
• Device Catalogue Number: M0035475200
• Device Lot Number: 23804327
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/06/2023; 02/12/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 12/13/2023; 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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 1018 MICROCATHETER (STRYKER)
• Patient Sex: Male