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

Catalog Number	M0035431030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the delivery wire was seen to be kinked/bent.The delivery wire was seen to be broken/fractured.The main coil was not returned.A functional inspection was unable to perform as the main coil wasn¿t returned.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 device was intended to be used for treatment.The reported 'coil in catheter friction' could not be replicated 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.It was reported that the coil got stuck in the microcatheter during insertion, and it could not be inserted even after several attempts.Additional information provided by the customer indicated that the resistance was noted while advancing the coil within the microcatheter.Additional info also indicated that the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter (with a slight buckling or reactive force indicating proper positioning) and the rhv (rotating hemostasis valve) was adequately tightened while the introducer sheath was in the hub and the rhv was opened enough to allow passage of the device through without damage.The device was analyzed and the main coil was detached due to a fracture of the delivery wire (pi wire) and the main coil was not returned.It is likely that the pi wire fractured due to the resistance encountered during delivery.An assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction' and to the as analyzed 'coil delivery wire broken/fractured during use' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' 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.
Event or Problem Description
The subject device was returned for analysis and it was discovered that the subject coil delivery wire was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.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: 20791884
• Report Number: 3008881809-2024-00569
• Device Sequence Number: 7791143
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: (01)04546540698018(17)270314(10)24830294
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K113412
• 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): 11/26/2024

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 Catalogue Number: M0035431030
• Device Lot Number: 24830294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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 SL-10 CATHETER (STRYKER)
• Patient Age: 22 YR
• Patient Sex: Male