MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 2 reports.Device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure physician was unable to deliver the subject coil out of the micro catheter.During the attempt to remove the subject coil from the patient¿s anatomy, it prematurely detached inside the micro catheter.The micro catheter was withdrawn from the patient¿s anatomy and the detached subject coil was removed along with it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received.The reported lot number was confirmed from the packaging label.During the visual inspection, the coil proximal contact was seen to be kinked bent.The delivery wire was seen to be kinked bent.The main coil was seen to be detached from the pusher wire.Functional testing was not carried out due to condition of returned 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 delivery wire and proximal contact were seen to be kinked bent, this can be presumed to have been caused by handling of the device.The as analyzed 'coil delivery wire kinked bent' and 'coil proximal contact kinked bent' will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure.The main coil was seen to be detached therefore the as reported will be confirmed and the as reported 'coil in catheter friction' and as reported/as analyzed 'main coil prematurely detached/separated during use' will be assigned procedural factors as it 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 the procedure physician was unable to deliver the subject coil out of the micro catheter.During the attempt to remove the subject coil from the patient¿s anatomy, it prematurely detached inside the micro catheter.The micro catheter was withdrawn from the patient¿s anatomy and the detached subject coil was removed along with it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 1MM X 2CM
• 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: 11349725
• Report Number: 3008881809-2021-00086
• Device Sequence Number: 11404182
• Product Code: HCG
• UDI-Device Identifier: 04546540698001
• UDI-Public: 04546540698001
• 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): 07/07/2021

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: 01/15/2023
• Device Model Number: M0035431020
• Device Catalogue Number: M0035431020
• Device Lot Number: 22054790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: EXCELSIOR MICRO CATHETER (STRYKER); LVIS STENT (MICROVENTION); SYNCHRO GUIDE WIRE (STRYKER); TARGET COIL (STRYKER); EXCELSIOR MICRO CATHETER (STRYKER); LVIS STENT (MICROVENTION); SYNCHRO GUIDE WIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 53 YR
• Patient Weight: 80