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

Model Number	M0035431020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject coil could not be fully detached.Upon removal of the subject coil, it had appeared that the coil had fractured and was retrieved by the microcatheter used during the procedure.The physician then replaced the subject coil and the microcatheter and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure the subject coil could not be fully detached.Upon removal of the subject coil, it had appeared that the coil had fractured and was retrieved by the microcatheter used during the procedure.The physician then replaced the subject coil and the microcatheter 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.During visual inspection, the subject main coil was returned manually detached and coil delivery wire was not returned.The distal tip was found to be intact and subject main coil was noted to be stretched.Functional test was not carried out as subject main coil was returned detached.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 and was prepared as per the dfu, continuous flush was maintained, no damage was sustained to the delivery wire during use, the patient's anatomy was moderately tortuous, and the coil fractured when it was attempted to be withdrawn back into the sl-10 microcatheter after failed detachment.The damage noted to the device would be indicative of the as reported defects.The main coil was seen to be stretched which may have caused detachment issues and the main coil probably broke/detached when it was attempted to be withdrawn back into the sl-10 microcatheter after failed detachment.A cause of procedural factors has been assigned to the reported and 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.

• 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 ; IE NA
• MDR Report Key: 9866834
• Report Number: 3008881809-2020-00073
• Device Sequence Number: 561064
• 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): 05/08/2020

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: 08/18/2022
• Device Model Number: M0035431020
• Device Catalogue Number: M0035431020
• Device Lot Number: 21680154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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 SL-10 (STRYKER); TARGET HELICAL NANO (STRYKER); EXCELSIOR SL-10 (STRYKER); TARGET HELICAL NANO (STRYKER)