MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL HELICAL 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036116200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the case of a carotid blowout from prior radiation of a neck tumor, the carotid was successfully shutdown with a two catheter technique using the microcatheters and coils, and the subject coil detached prematurely from the middle section inside the patient¿s anatomy during procedure.The coil pusher and a portion of the coil were successfully retracted by the physician.A portion of the detached coil stayed inside the patient¿s anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the case of a carotid blowout from prior radiation of a neck tumor, the carotid was successfully shutdown with a two catheter technique using the microcatheters and coils, and the subject coil detached prematurely from the middle section inside the patient¿s anatomy during procedure.The coil pusher and a portion of the coil were successfully retracted by the physician.A portion of the detached coil stayed inside the patient¿s anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Analysis of the device revealed that the subject coil was/was not fractured/broken during use; therefore, based on this information the event is deemed non-reportable and emdr redaction will be filed with an aware date of 08-may-2020.The event will be re-assessed to reflect the decision change and emdr will be filed accordingly.
Additional Manufacturer Narrative
B5 executive summary- not applicable.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.H1 type of reportable event - not applicable.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached ¿ updated.H6 patient code grid - updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.On visual inspection, the proximal contact wire was intact.The coil delivery wire was kinked/bent.The distal tip was found to be intact.The main coil was severely stretched.The entire main coil was returned.On functional testing, the reported defect main coil broken/fractured inside patient was not confirmed.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 main coil broken/fractured during use was not confirmed during analysis.Therefore, an assignable cause of ¿not confirmed¿ was assigned to the reported ¿main coil broken/fractured during use¿, as the main coil was not broken or fractured.It is probable that the physician perceived the main coil stretching to be main coil broken/fractured.The analyzed ¿main coil stretched¿ was assigned ¿procedural factors¿ as this defect appears 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 analyzed ¿coil delivery wire kinked/bent¿ was 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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET XL HELICAL 6MM X 20CM
• 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: 9803277
• Report Number: 3008881809-2020-00059
• Device Sequence Number: 642978
• Product Code: HCG
• UDI-Device Identifier: 07613327004588
• UDI-Public: 07613327004588
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 05/11/2020

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: 01/31/2021
• Device Model Number: M0036116200
• Device Catalogue Number: M0036116200
• Device Lot Number: 20253770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: P400 COILS (UNKNOWN MANUFACTURER); PX SLIM CATHETER (UNKNOWN MANUFACTURER)