MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2nd of 2 mdr reports.The subject device not returned.
Event or Problem Description
It was reported that during the balloon assisted coiling procedure, the coil (subject device) was prematurely detached from the delivery wire.The coil was removed from the patient anatomy within the microcatheter.There were no clinical consequences to the patient and the procedure was completed successfully.
Additional Manufacturer Narrative
D4: expiration date: added.D10/h3: product available to stryker: corrected.H4: manufacturing date: added.H3: reason for no evaluation: corrected.H3: reason code ¿ other: corrected.H3: summary attached: updated.The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The reported complaint was not confirmed, and it cannot be definitively determined that the device met specification, as the device 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.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use and continuous flush was maintained.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported issue main coil prematurely detached/separated inside the patient.H3 other text : the subject device not returned.
Event or Problem Description
It was reported that during the balloon assisted coiling procedure, the coil (subject device) was prematurely detached from the delivery wire.The coil was removed from the patient anatomy within the microcatheter.There were no clinical consequences to the patient and the procedure was completed successfully.

• Brand Name: TARGET 360 ULTRA 2MM X 3CM
• 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: 9378539
• Report Number: 3008881809-2019-00369
• Device Sequence Number: 11523006
• Product Code: HCG
• UDI-Device Identifier: 04546540675835
• UDI-Public: 04546540675835
• 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
• Report Date (Section B): 01/21/2020

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: 09/02/2022
• Device Model Number: M0035422030
• Device Catalogue Number: M0035422030
• Device Lot Number: 21718827
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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: EXCELSIOR SL-10 MICROCATHTER (STRYKER)