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	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.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.During visual inspection, the coil delivery wire was kinked/bent and broken/fractured.The main coil was also noted to be kinked/bent.During functional testing, the coil was flushed, inserted and advanced in a demonstration catheter.The coil could not be advanced completely when the fractured on the delivery wire was reached.Additional information provided by the customer indicated that the device was confirmed to be in a good condition prior to use and prepared as per dfu, continuous flush was maintained throughout the procedure, the patient¿s anatomy was moderately tortuous and a non-stryker microcatheter (echelon 10) was used.The device was returned for analysis and the main coil was found to be kinked.The damage noted to the main coil is indicative of the as reported defect.It is likely that the physician experienced friction in the microcatheter due to procedural factors during use which subsequently led to coil damage when it was advanced against resistance.Based on the investigation, these defects appear 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 or anatomical factors during use.Therefore, a probable cause of procedural factors was assigned to the as reported event coil in catheter friction as well as the as analyzed event main coil kinked/bent.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied at the proximal end of the device when friction was felt in the microcatheter causing the delivery wire to kink and then break.Because these defects appear to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned to the as reported/as analyzed events coil delivery wire kinked bent and the as analyzed coil delivery wire broken/fractured inside patient.
Event or Problem Description
Analysis of the returned device found that the delivery wire of the subject coil was found broken/fractured inside patient.There were no clinical consequences to the patient as a result of this event.

• 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: 9639844
• Report Number: 3008881809-2020-00024
• Device Sequence Number: 2678497
• 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
• Report Date (Section B): 01/28/2020

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: 10/23/2021
• Device Model Number: M0035431020
• Device Catalogue Number: M0035431020
• Device Lot Number: 20957207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 77