MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the coil (subject device) prematurely detached in the catheter.The procedure was completed successfully with no clinical consequences reported to the patient due to this event.
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 and kinked/bent.The coil delivery wire was seen to be kinked/bent.Functional testing was unable to perform due to the returned condition of 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 reported event could not be duplicated 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 the analyzed anomalies noted to the device.Additional information provided by the customer is that 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.During the analysis, it was noted that the coil delivery wire was kinked, and the main coil was detached from the delivery wire and kinked.An assignable cause of procedural factors will be assigned to reported event of the main coil failed/unable to detach as as this defect 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 analyzed damage of the main coil prematurely detached/separated during use and the main coil kinked/bent as this defect 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 damage of the coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product during the clinical procedure.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H6 investigation findings - results code grid - updated.H6 investigation conclusions - conclusion code grid - 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 visual inspection the main coil was seen to be detached/separated (after the procedure, the operator tried to detach the complained coil on the table and the coil was detached then).The main coil was kinked/bent.The coil delivery wire was seen to be kinked/bent.Functional testing was unable to perform due to the returned condition of 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 reported event could not be duplicated 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 the analyzed anomalies noted to the device.Additional information provided by the customer is that 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.4 attempts were made to detach the coil.The ¿current flow¿ indicator illuminated solid green after ¿detachment¿ button was pressed.Another detachment device which was not complained about was used to detach the complained coil.After the procedure, the operator tried to detach the complained coil on the table and the coil was detached then.During the analysis, it was noted that the coil delivery wire was kinked, and the main coil was detached from the delivery wire and kinked.An assignable cause of procedural factors will be assigned to the reported event of the main coil failed/unable to detach as this defect 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.The analyzed damage of the main coil prematurely detached/separated during preparation, main coil kinked/bent, and coil delivery wire kinked/bent have been assigned handling damage 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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the coil (subject device) prematurely detached in the catheter.The procedure was completed successfully with no clinical consequences reported to the patient due to this event.Updated: review of information received from cic on 16-oct-2023 clarified that the subject coil was detached by the physician on the table outside of the patient¿s body and not during the procedure.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 1MM X 3CM
• 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: 18369266
• Report Number: 3008881809-2023-00594
• Device Sequence Number: 7807019
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/16/2024

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: 04/16/2026
• Device Catalogue Number: M0035431030
• Device Lot Number: 24298804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian