MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a neurovascular procedure, when the subject coil was close to the distal tip of the microcatheter, it was evident that the subject coil began to twist, taking its helical shape inside the microcatheter.The subject coil got stuck and did not advance to the aneurysm.The operator retracted the subject coil and then advanced it again but the subject coil got stuck again and did not advance.Therefore he decided to remove the subject coil.A unknown medical intervention was reported due to this event.Surgical delay of 5 minuets was noted.In addition the filling of the aneurysm could not be finished.
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.The device was analyzed, thee coil delivery wire was seen to be kinked/bent and the main coil was seen to be kinked and stretched.Although the as reported could not be confirmed; however, the analysis results are consistent with the reported event.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.An assignable cause of procedural factors will be assigned to the as reported patient medical or surgical intervention required, main coil tangled and 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 '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.An assignable cause of procedural factors will be assigned to the as analyzed main coil stretched and main coil kinked/bent 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.
Event or Problem Description
It was reported that during a neurovascular procedure, when the subject coil was close to the distal tip of the microcatheter, it was evident that the subject coil began to twist, taking its helical shape inside the microcatheter.The subject coil got stuck and did not advance to the aneurysm.The operator retracted the subject coil and then advanced it again but the subject coil got stuck again and did not advance.Therefore he decided to remove the subject coil.A unknown medical intervention was reported due to this event.Surgical delay of 5 minuets was noted.In addition the filling of the aneurysm could not be finished.

• Brand Name: TARGET HELICAL NANO 1.5MM X 4CM
• 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: 17339643
• Report Number: 3008881809-2023-00356
• Device Sequence Number: 20568178
• Product Code: HCG
• UDI-Device Identifier: 04546540698056
• UDI-Public: 04546540698056
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2024
• Device Model Number: M0035431540
• Device Catalogue Number: M0035431540
• Device Lot Number: 23153622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 70 KG