MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431530
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
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) was prematurely detached inside the catheter.No clinical consequences were 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.The device was returned and the lot number was not confirmed as there was no packaging returned.During visual inspection the coil delivery wire was seen to be kinked/bent.The main coil was seen to be separated.The main coil was pushed out of the catheter device with the appropriate mandrel and the introducer sheath was found to be intact.The main coil was found to be intact.There was no damage/defect to the catheter.Functional testing was 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 coil in catheter friction could not be confirmed; however, the analysis results are consistent with the reported event.The device was analyzed and the coil delivery wire was noted to be kinked/bent and the main coil was returned detached.There was no anomalies on the coil.There was no information on the coil being detached therefore, during use will be assigned.An assignable cause of procedural factors will be assigned to the reported event of coil in catheter friction 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 not confirmed will be assigned to the reported event of the main coil stretched as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.An assignable cause of procedural factors will be assigned to the analyzed event of the 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 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.

• Brand Name: TARGET HELICAL NANO 1.5MM 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: 17385164
• Report Number: 3008881809-2023-00373
• Device Sequence Number: 6083610
• Product Code: HCG
• UDI-Device Identifier: 04546540698049
• UDI-Public: 04546540698049
• 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
• Report Date (Section B): 07/24/2023

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: 04/29/2025
• Device Catalogue Number: M0035431530
• Device Lot Number: 22254100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2020
• 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: SL-10 CATHETER (STRYKER)
• Patient Sex: Male