MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452060
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and the lot number was confirmed.During visual inspection, the coil delivery wire was seen to be broken, and was seen to be kinked bent.The main coil was seen to be kink bent and stretched.During the functional inspection, the coil could not be advanced due to the damage.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that preparation/set-up was performed as per the dfu and the same microcatheter was used to complete the procedure after changing to different size coils.The device was returned for analysis and the main coil was found to be kinked and stretched.The damage noted to the main coil is indicative of the as reported defect.It is likely that the coil was damaged due to procedural factors during use which resulted in friction experienced during manipulation of the coil in the catheter.Introducer sheath friction was also noted during analysis due to the damaged coil.It can be presumed that the delivery wire kinked and subsequently broke during the procedure as excessive force may have been applied in response to the reported catheter friction.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 and/or anatomical factors during use.Therefore, a probable cause of procedural factors and handling damage will be assigned to the event.
Event or Problem Description
The coil was returned for analysis and it was discovered that the delivery wire of the subject coil was kinked and subsequently broken during the procedure.The subject coil was also found to be kinked, bent and stretched.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 2MM X 6CM
• 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: 10214726
• Report Number: 3008881809-2020-00187
• Device Sequence Number: 13980128
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: 07613252600381
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 06/30/2020

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: 08/26/2022
• Device Model Number: M0035452060
• Device Catalogue Number: M0035452060
• Device Lot Number: 21688348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR