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

Model Number	M0035431540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned within the distal tip of a echelon 10 microcatheter.The lot number was confirmed with the packaging returned with the device.During visual inspection, a syncro guide wire inserted through the hub of the microcatheter.The coil was removed during analysis from the microcatheter and was noted to be kinked in several locations.It was also noted to have been physically detached from the delivery wire which was not returned.A demonstration introducer sheath was inserted into the hub of the microcatheter and a gap was noted between the catheter shaft and the introducer sheath.Functional testing was unable to be performed as the coil had been detached.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 complaint could not be confirmed, however the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted.Additional information provided by the customer indicated that the device was prepared/set-up as per the directions for use with continuous flush being implemented.The coil delivery wire was kinked/bent and the main coil had separated from the delivery wire (which was not returned) and was kinked/bent in several places along its length.This complaint appears to be associated with a product that met stryker design and manufacturing specifications but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to the main coil kinked and bent, coil and catheter incompatible, and the main coil prematurely detached and separated during use complaint.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the coil (subject device) detached from the delivery wire during the procedure.No clinical consequences were reported to the patient due to this event.

• 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
• MDR Report Key: 12068468
• Report Number: 3008881809-2021-00276
• Device Sequence Number: 11803702
• Product Code: HCG
• UDI-Device Identifier: 04546540698056
• UDI-Public: 04546540698056
• 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
• Report Date (Section B): 06/25/2021

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: 10/18/2023
• Device Model Number: M0035431540
• Device Catalogue Number: M0035431540
• Device Lot Number: 22503038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 CATHETER (COVIDIEN)
• Patient Age: 57 YR
• Patient Weight: 52