MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035434060
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that the delivery wire of the coil was broken when inserted into the microcatheter.No patient consequences were reported due to this event.
Event or Problem Description
It was reported that the delivery wire of the coil was broken when inserted into the microcatheter.No patient consequences were reported due to this event.
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 direction 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.In case of this complaint, the reported complaint was not confirmed.Based on analysis it was found that the delivery wire was not broken/fractured but the proximal contact was broken/fractured and this may have been perceived as being broken; therefore, an assignable cause of handling damage was assigned to the as analyzed coil proximal issue, since the issue appears to be associated with handling of the product or portion of the product/upon removal of the product from the packaging/preparation of the product prior to use.The proximal contact is not a contiguous part that forms the delivery wire but is a subcomponent location at the proximal end of the delivery wire that works in conjunction with the inzone detachment system, and it remains outside the patient at all times during the procedure.It is highly unlikely that the detached/separated proximal contact may contributed to and/or cause any patient injury; the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question with an awareness date of 25 - nov -2019.
Event or Problem Description
It was reported that the delivery wire of the coil was broken when inserted into the microcatheter.No patient consequences were reported due to this event.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not 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.As this device was not returned as assignable cause of undetermined was assigned to the as reported issue coil delivery wire broken, since the review of all available information failed to indicate a probable cause.

• Brand Name: TARGET HELICAL ULTRA 4 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8935763
• Report Number: 3008881809-2019-00252
• Device Sequence Number: 2559911
• Product Code: HCG
• UDI-Device Identifier: 04546540676108
• UDI-Public: 04546540676108
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AU
• 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): 12/17/2019

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: 09/30/2019
• Device Catalogue Number: M0035434060
• Device Lot Number: 19289659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 10/02/2019; 11/25/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/22/2019; 12/17/2019
• 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: MICROCATHETER (UNKNOWN MANUFACTURER); MICROCATHETER (UNKNOWN MANUFACTURER)