MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036119300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 3 reports.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject coil was noted to be stretched and had prematurely detached during use.The subject device was removed.The physician replaced with another of the same device and completed the procedure successfully.The patient was stable and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.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 no issues were noted to the coil when it was inspected prior to use.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to the reported complaint.
Event or Problem Description
It was reported that during the procedure the subject coil was noted to be stretched and had prematurely detached during use.The subject device was removed.The physician replaced with another of the same device and completed the procedure successfully.The patient was stable and no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9: returned to manufacturer on: updated.D9/h3: product available to stryker: updated.H1: summary report / number of events: updated.H2: follow-up type: updated.H3: device evaluated by mfg: updated.H3: summary attached: updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Device was returned for analysis and product lot number was not confirmed as packaging was not returned.During visual inspection, it was noted that subject main coil was detached and was not returned with the delivery wire.The main coil was manually detached and the proximal contact wire and coil delivery wire seen to be kinked / bent.Functional tests could not be carried out as the main coil was not returned.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 damage noted to the device would be indicative of the as reported defect.The as reported/as analyzed event will be assigned procedural factors as the 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 reported defect of main coil stretched was not confirmed however, the analysis results are consistent with the event.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Because this defect appears to be associated with handling of the product or portion of the product during the procedure / upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage will be assigned to the as analyzed events coil proximal contact kinked / bent and coil delivery wire kinked / bent.
Event or Problem Description
It was reported that during the procedure the subject coil was noted to be stretched and had prematurely detached during use.The subject device was removed.The physician replaced with another of the same device and completed the procedure successfully.The patient was stable and no clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 1.5MM 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: 9942111
• Report Number: 3008881809-2020-00097
• Device Sequence Number: 14182165
• Product Code: HCG
• UDI-Device Identifier: 04546540711519
• UDI-Public: 04546540711519
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/05/2020

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: 04/16/2022
• Device Model Number: M0036119300
• Device Catalogue Number: M0035431520
• Device Lot Number: 21374699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 05/13/2020; 07/27/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/14/2020; 08/05/2020
• 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: SL1018/SL10 MICROCATHETER (STRYKER); SL1018/SL10 MICROCATHETER (STRYKER)