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

Model Number	M0035431020
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
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 returned within the introducer sheath.The lot number was confirmed with the packaging returned with the device.During visual inspection, the proximal contact wire was intact, the coil delivery wire was kinked/bent, the main coil was detached in the introducer sheath and was cut to remove the coil.The distal tip was found to be intact, the main coil was stretched and kinked/bent.Functional testing was not carried out due to the condition of the 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, preparation/set-up was performed as per the dfu and continuous flush was maintained for the duration of the procedure.So, an assignable cause of procedural factors will be assigned to the as reported and as analyzed events as these defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.The as analyzed coil delivery wire kinked bent will be assigned handling damage 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
It was reported that during the procedure while the subject coil was delivered to the end of the microcatheter the operator felt resistance and was unable to deploy the subject coil.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Analysis of the device revealed that the main coil had prematurely deployed; therefore, based on this information the event is deemed reportable and emdr will be filed with an aware date of 16-jul-2020.The event will be assessed to reflect the decision change and emdr will be filed accordingly.
Additional Manufacturer Narrative
B5 ¿ executive summary ¿ corrected f10/h6 ¿ device code ¿ corrected.
Event or Problem Description
During the analysis of the returned device, it was revealed that the subject main coil was prematurely detached/separated during use.No clinical consequences reported 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: 10285607
• Report Number: 3008881809-2020-00211
• Device Sequence Number: 485127
• Product Code: HCG
• UDI-Device Identifier: 04546540698001
• UDI-Public: 04546540698001
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 05/07/2021

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: 07/08/2022
• Device Model Number: M0035431020
• Device Catalogue Number: M0035431020
• Device Lot Number: 21578683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 05/07/2021
• 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: AXIUM DETACHABLE COILS (MEDTRONICS); SL-10 MICRO CATHETER (STRYKER); SYNCHRO GUIDE WIRE (STRYKER)
• Patient Age: 54 YR
• Patient Weight: 58