MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
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 the procedure when the coil (subject device) was delivered to the lesion the distal tip was observed to be thin.The coil (subject device) was retrieved and the distal tip was found to be stretched and fractured.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported, that during the procedure.When the coil (subject device) was delivered to the lesion, the distal tip was observed, to be thin.The coil (subject device) was retrieved and the distal tip was found to be stretched and fractured.The physician replaced it with a new device.And continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
B1: adverse event/product problem? corrected, no product problem; h1: type of reportable event? corrected.No malfunction; d4: expiration date? added; d9; product available to stryker? updated; d9: returned to manufacturer on? updated; h4: manufacturing date? added; h3: device evaluated by mfg? updated; h3: summary attached? updated.Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned with a non-stryker microcatheter.During visual inspection, the coil delivery wire was seen to be kinked.The main coil was seen to be kinked and stretched.Despite the damage, the main coil was returned complete.No brake or fracture was noted.Functional testing was not completed, due to device condition.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 main coil broken/fractured, during use was not confirmed, based on the device analysis.The reported event main coil stretched 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, indicated that no damage was noted, to the packaging, prior to opening.The device was confirmed, to be in good condition, during preparation/prior to use on the patient.And was prepared as per, the dfu.The device was analyzed.And it was noted, that the main coil was kinked/bent and stretched and despite the damage the main coil was returned complete.No brake or fracture was noted.Based on the visual inspection, the reportable event of main coil broken/fractured, during use was not confirmed.The as reported event of main coil stretched was confirmed, based on visual inspection.An assignable cause of not confirmed, will be assigned to the as reported event of main coil broken/fractured, during use.As the event was not confirmed, during the analysis.An assignable cause of procedural factors will be assigned to the as reported and as analyzed event of main coil stretched.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 procedural factors will be assigned to the as analyzed event of main coil 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 event of coil delivery wire kinked/bent, as the defect appears to be associated with handling of the product or portion of the product during preparation.The manufacturer has reviewed all information and determined, this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 SOFT 4MM X 8CM
• 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: 18260815
• Report Number: 3008881809-2023-00568
• Device Sequence Number: 12727591
• Product Code: HCG
• UDI-Device Identifier: 04546540676467
• UDI-Public: 04546540676467
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 02/08/2025
• Device Catalogue Number: M0035474080
• Device Lot Number: 23464654
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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)
• Patient Sex: Unknown